2AMYMSM9110Wireless TENS&EMS

Section 10 Proposed Labeling [As required by 21 CFR 807.87(e)] 1-34 User Manual SM9110 main unit SM9110 remote control SM9 Indications for Use Over-The-Counter Use: TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm,and leg, due to strain from exercise or normal household and work activities. PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. Prescription Use: TENS (Transcutaneous Electric Nerve Stimulation): Symptomatic relief and management of chronic, intractable pain; Adjunctive treatment for post-surgical and post-trauma acute pain. PMS (Powered Muscle Stimulation): Temporary relaxation of muscle spasm; Prevention or retardation of disuse atrophy; Muscle re-education; Maintaining or increasing range of motion; Increase of local blood flow in the treatment area; Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles. Section 10 Proposed Labeling [As required by 21 CFR 807.87(e)] 2-34 Before operation, please read this user’s manual carefully, and be clear about the instructions! 2023-03-15 Version: 1.0 Section 10 Proposed Labeling [As required by 21 CFR 807.87(e)] 3-34 Contents Page I. Foreword 3 Syncing the remote control and the TENS&PMS 3 II. 1. Description of the Device 4 2. Contents 4 3. Mode description 5 4. Battery Replacement or charging 6 4.1 Charging the Battery 6 4.2 Replace the battery 6 III. User Instruction 12 Section 1 - For TENS purpose 12 1.1 Indications for Use 12 1.2 Safety 12 1.3 Preparation for use 14 1.3.1 Preparation of Electrode gels 14 1.3.2 Skin Preparation 15 1.3.3 Conducting a Treatment 15 1.4 Removing the device 15 1.5 Regular TENS Application principle 15 1.6 Regular TENS Application Methods 16 Section 2 - For PMS purpose 18 2.1 Indications for Use 18 2.2 Safety 19 2.3 Preparation for use 20 2.3.1 Preparation of Electrode gels 20 2.3.2 Skin Preparation 20 2.3.3 Conducting a Treatment 21 2.4 Removing the device 21 2.5 Regular PMS Application principle 21 2.6 Regular PMS Application Methods 22 IV. Troubleshooting 24 V. Service and Maintenance 25 1. Cleaning and maintenance 25 2. Storage 25 3. Disposal 25 4. Warranty period 25 5. Manufacturer information 25 VI. Technical specifications 26 Appendix A Labels on the device 29 Appendix B Electromagnetic compatibility 30 Section 10 Proposed Labeling [As required by 21 CFR 807.87(e)] 4-34 I. Foreword It is important to read the entire contents of this instruction for user manual before using your Wireless TENS & EMS. The warnings, contraindications and subsequent chapters contained within this manual are intended to help ensure proper use and optimal results. Symbol Meaning Type BF applied part Manufacturer Follow the instructions for use Serial Number Denotes a product which must be disposed of safely Attention, see instructions for use Waterproof IP Rating Manufacturing date (Month/Year) 1. Five key points for operations 1) This device is intended for use on healthy skin. 2) The electrode pads are for single patient use. 3) Intensity is based upon your level of comfort. 4) Begin the first session with a low intensity and a short duration while learning how to operate. 5) If you feel pain, dizziness, or discomfort, call your physician. 2.Syncing the remote control and the Wireless TENS & EMS If your remote control and main unit ever lose communication, please repeat these syncing instructions. 1） Make sure the main unit has enough power, charge it if not. 2） Make sure the remote control has enough power, charge it if not. 3） Firstly turn on the switch button of Wireless TENS & EMS, then click the ON/OFF button of remote control. The remote control and your main unit will connected automatically. ▲ Note: * Your remote control and main unit can’t connected with other device during the communication. * The LED of Wireless TENS & EMS flashes means it’s ready for use. Section 10 Proposed Labeling [As required by 21 CFR 807.87(e)] 5-34 II. Description of the Device 1. Introduction Congratulations on your purchase of the Wireless TENS & EMS (Model SM9110). It is a unique wireless remote controlled device that includes Wireless TENS & EMS technology. The flexible design perfectly contours the target areas for maximum surface contact. This device is safe, drug-free, easy to use, discreet and comfortable to wear, and most importantly allows you to control your pain or exercise healthy muscle. 2. Contents • 1 x Main unit • 2 x Set of electrode pads [K183154] • 1 x USB charging cable • 1 x Remote control • User Manual Main unit (built-in lithium battery) Electrode Pad - Butterfly [K183154] Size: 218×90mm USB cable (31’’) 80cm Remote control Icon and function Icon Explanation ① Switch of Wireless TENS & EMS ② On/Off button: Press to turn on/off the remote control + / - Press to increase or decrease stimulation intensity M Press to select treatment mode ►II Pause or start ① ② Section 10 Proposed Labeling [As required by 21 CFR 807.87(e)] 6-34 Introduction of the remote controls * SM9110- Blue Remote control The LCD of the blue remote control displays cure mode, cure time, intensity and battery level of the remote control. There are six mode icons for users to identify different modes,each of which has 1,2,3, and 4 submodes . Once you select a mode, the corresponding mode icon will flash. There are twenty small black squares for intensity level, each of which represents 1 levels of intensity. 3. Product operation function description The Main unit can be used alone or in conjunction with the remote control When the Main unit works alone : 1. Fully charge the Main u…

Text truncated - open the document above for the full version.

SC3078002

External Photos

Internal Photos

FCC ID: 2AMYMSM9110 RF Exposure Evaluation REQUIREMENT KDB447498 D01 General RF Exposure Guidance v06, Clause 4.3.1(a) [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] · [√f(GHz)] ≤ 7.5 Where -f(GHz) is the RF channel transmit frequency in GHz -Power and distance are rounded to the nearest mW and mm before calculation -The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm, and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 4.1 f) is applied to determine SAR test exclusion. TEST RESULT Passed Not Applicable Radio Type Frequency range (MHz) Conducted Average Power (dBm) Maximum Tune-up (dBm) Calculating data Limit Result FSK 2402~2481 -3.86 -3.00 0.1579 7.5 Pass Note: 1) The maximum antenna gain is 2dBi 2) The exposure evaluation safety distance is 0mm.

Page: 1 of 33 TEST REPORT For 2.4G Report No. ...................................... : CHTEW23050048 Report Verification: Project No.................................： SHT2204077913EW FCC ID ............................................. : 2AMYMSM9110 Applicant’s name ........................... : Hong Qiangxing(Shenzhen) electronics Limited Address ............................................. : 2F,Yongcheng Blvd,Xicheng Industrial area,Xixiang Street,Bao'an District,Shenzhen City, Guangdong Province, China 518126 Product Name ................................ : Wireless TENS&EMS Trade Mark ....................................... : - Model No. ......................................... : SM9110 main unit Listed Model(s) ................................. : - Standard ......................................... : FCC CFR Title 47 Part 15 Subpart C § 15.247 Date of receipt of test sample..........: Apr.26, 2023 Date of testing.............................: Apr.26, 2023-May.15, 2023 Date of issue...............................: May.16, 2023 Result .................. ........................: PASS Compiled by ( Position+Printed name+Signature): File administrator Fanghui Zhu Supervised by (Position+Printed name+Signature): Project Engineer Kiki Kong Approved by (Position+Printed name+Signature): RF Manager Hans Hu Testing Laboratory Name ............. : Shenzhen Huatongwei International Inspection Co., Ltd. Address ............................................. : 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Shenzhen Huatongwei International Inspection Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen Huatongwei International Inspection Co., Ltd. is acknowledged as copyright owner and source of the material. Shenzhen Huatongwei International Inspection Co., Ltd. takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. The test report merely correspond to the test sample. Report No.: CHTEW23050048 Page: 2 of 33 Date of issue: 2023-05-16 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05(2023-03) Contents 1. TEST S T AN D AR D S A N D R E P O R T V E R S I O N 3 1.1. Test Standards 3 1.2. Report version 3 2. TEST DESCRIPTION 4 3. SUMMARY 5 3.1. Client Information 5 3.2. Product Description 5 3.3. Radio Specification Description 5 3.4. Testing Laboratory Information 6 4. TEST CONFIGURATION 7 4.1. Test frequency list 7 4.2. Descriptions of Test mode 7 4.3. Test sample information 7 4.4. Support unit used in test configuration and system 8 4.5. Testing environmental condition 8 4.6. Statement of the measurement uncertainty 8 4.7. Equipment Used during the Test 9 5. TEST CONDITIONS AND RESULTS 10 5.1. Antenna Requirement 10 5.2. AC Conducted Emission 11 5.3. Peak Output Power 13 5.4. Power Spectral Density 14 5.5. 6dB bandwidth 15 5.6. 99% Occupied Bandwidth 16 5.7. Duty Cycle 17 5.8. Conducted Band edge and Spurious Emission 18 5.9. Radiated Band edge Emission 19 5.10. Radiated Spurious Emission 21 6. TEST SETUP PHOTOS 26 7. EXTERNAL AND INTERNAL PHOTOS 28 7.1. External Photos 28 7.2. Internal Photos 31 8. APPENDIX REPORT 33 Report No.: CHTEW23050048 Page: 3 of 33 Date of issue: 2023-05-16 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05(2023-03) 1. TEST STAND ARDS AND REPORT VERSION 1.1. Test Standards The tests were performed according to following standards: ‒ FCC CFR Title 47 Part 15 Subpart C § 15.247: Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz ‒ ANSI C63.10:2020: American National Standard for Testing Unlicensed Wireless Devices ‒ KDB 558074 D01 15.247 Meas Guidance v05r02: Guidance for Compliance Measurements on Digital Transmission System, Frequency Hopping Spread Spectrum System, and Hybrid System Devices Operating under Section 15.247 of The FCC Rules 1.2. Report version Revision No. Date of issue Description N/A 2023-05-16 Original Report No.: CHTEW23050048 Page: 4 of 33 Date of issue: 2023-05-16 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05(2023-03) 2. TEST DESCRIPTION Report clause Test Items Standard Requirement Result Test Engineer 5.1 Antenna Requirement 15.203/15.247(c) PASS Xiaoqin Li 5.2 AC Conducted Emission 15.207 PASS Dongyang Wu 5.3 Peak Output Power 15.247(b)(3) PASS Xiaoqin Li 5.4 Power Spectral Density 15.247(e) PASS Xiaoqin Li 5.5 6dB Bandwidth 15.247(a)(2) PASS Xiaoqin Li 5.6 99% Occupied Bandwidth - PASS *1 Xiaoqin Li 5.7 Duty cycle - PASS *1 Xiaoqin Li 5.8 Conducted Band Edge and Spurious Emission 15.247(d)/15.205 PASS Xiaoqin Li 5.9 Radiated Band Edge Emission 15.205/15.209 PASS Quanhai Deng 5.10 Radiated Spurious Emission 15.247(d)/15.205/15.209 PASS Haoxin Luo Note: ‒ The measurement uncertainty is not included in the test result. ‒ *1: No requirement on standard, only report these test data. Report No.: CHTEW23050048 Page: 5 of 33 Date of issue: 2023-05-16 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V05(2023-03) 3. SUMMARY 3.1. Client Information Applicant: Hong Qiangxing(Shenzhen) electronics Limited Address: 2F,Yongcheng Blvd,Xicheng Industrial area,Xixiang Street,Bao'an District,Shenzhen City, Guangdong Province, China 518126 Manufacturer: Hong Qiangxing(Shenzhen) electronics Limited Address: 2F,Yongcheng Blvd,Xicheng Industrial area,Xixiang Street,Bao'an District,Shenzhen City, Guangdong Province, China 518126 3.2. Product Description Main unit information: Product Name: Wireless TENS&EMS Trade Mark: - Model No.: SM9110 main unit Listed Model(s): - Power supply: DC 3.7V from Battery Hardware version: V5.2 Software version: 20210602010Y3masterV1.1 Accessory unit information: Battery information: Model: 042230 Nominal Voltage: 3.7V Rated Capacity: 18…

Text truncated - open the document above for the full version.

Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 1 of 14 APPENDIX REPORT Project No. SHT2204077913EW Test sample No. YPHT22040779022 Model No. SM9110 main unit Start test date 2023-05-12 Finish date 2023-05-12 Temperature 24.4°C Humidity 48% Test Engineer Xiaoqin Li Auditor Appendix clause Test item Result A Peak Output Power PASS B Power Spectral Density PASS C 6 dB Bandwidth PASS D 99% Occupied Bandwidth PASS E Duty cycle PASS F Band edge and Spurious Emissions (conducted) PASS Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 2 of 14 Appendix A：Peak Output Power Type Channel Peak Output power (dBm) Average Output power (dBm) Limit (dBm) Result FSK 00 -4.37 -4.40 ≤ 30.00 Pass 38 -4.23 -4.26 79 -3.83 -3.86 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 3 of 14 CH00 Date: 12.M AY.2023 14:38:31 CH38 Date: 12.M AY.2023 14:42:38 CH79 Date: 12.M AY.2023 14:44:48 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 4 of 14 Appendix B：Power Spectral Density Type Channel Power Spectral Density(dBm/3KHz) Limit (dBm/3KHz) Result FSK 00 -21.10 ≤8.00 Pass 38 -20.86 79 -21.00 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 5 of 14 CH00 Date: 12.M AY.2023 14:38:45 CH38 Date: 12.M AY.2023 14:42:53 CH79 Date: 12.M AY.2023 14:45:03 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 6 of 14 Appendix C：6dB bandwidth Type Channel 6dB Bandwidth(kHz) Limit (kHz) Result FSK 00 1105.00 ≥500 Pass 38 1880.00 79 1380.00 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 7 of 14 CH00 Date: 12.M AY.2023 14:38:15 CH38 Date: 12.M AY.2023 14:42:23 CH79 Date: 12.M AY.2023 14:44:33 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 8 of 14 Appendix D：99% Occupied Bandwidth Type Channel 99% Occupied Bandwidth(MHz) Limit (kHz) Result FSK 00 1.33 - Pass 38 2.18 79 1.70 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 9 of 14 CH00 Date: 12.M AY.2023 14:38:23 CH38 Date: 12.M AY.2023 14:42:30 CH79 Date: 12.M AY.2023 14:44:40 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 10 of 14 Appendix E：Duty cycle Test Frequency （MHz） T on time for single burst (ms) T period (ms) Duty cycle 1/T on time (kHz) 2440 0.16 1.72 9.3% 6.25 Date: 12.M AY.2023 14:41:56 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 11 of 14 Appendix F：Band edge and Spurious Emissions (conducted) Test Item: Band edge CH00 Date: 12.M AY.2023 14:38:54 CH79 Date: 12.M AY.2023 14:45:12 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 12 of 14 Test Item: SE CH00 Reference level Date: 12.M AY.2023 14:39:00 CH00 30MHz~1000MHz Date: 12.M AY.2023 14:39:15 CH00 1GHz~26GHz Date: 12.M AY.2023 14:39:35 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 13 of 14 CH38 Reference level Date: 12.M AY.2023 14:42:58 CH38 30MHz~1000MHz Date: 12.M AY.2023 14:43:13 CH38 1GHz~26GHz Date: 12.M AY.2023 14:43:28 Project No.: SHT2204077913EW Radio Specification: 2.4G Shenzhen Huatongwei International Inspection Co., Ltd. Appendix report page: 14 of 14 CH79 Reference level Date: 12.M AY.2023 14:45:17 CH79 30MHz~1000MHz Date: 12.M AY.2023 14:45:32 CH79 1GHz~26GHz Date: 12.M AY.2023 14:45:55 --------End of Report--------

Antenna Specification Specifications Summary ITEM SPEC Center Frequency 2450MHz MAX GAIN 2dBi Polarization Horizontal Azimuth Beam Pattern Omni-directional Impedance 50Ω Antenna Length 4.1cm Supplier SUNMAS Supplier Address 4 / F, Yongchang Building, Xicheng Industrial Zone, Xixiang, Bao 'an District, Shenzhen City Antenna Photo&Length(mm) 1、Horizontal Frequency(MHz): 2450 Antenna Polarity: Horizontal 5dB/div Ref Lev:9.5dBm 2、Vertical Frequency(MHz): 2450 Antenna Polarity: Vertical 5dB/div Ref Lev:-2.0dBm

TEST SETUP PHOTOS Radiated Emission AC Conducted Emission