(309 days)
The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
- The big belt is intended for use on the muscles in abdomen.
- The small belt is intended for use on the muscles in arms and thighs areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes.
The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level and frequency level can be adjusted by user.
This document is a 510(k) summary for the SM9065 Fitness Belt, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to already marketed predicate devices rather than presenting a standalone study with acceptance criteria in the typical sense for clinical performance.
Here's a breakdown of the requested information based on the provided text, recognizing the nature of a 510(k) submission for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (a powered muscle stimulator for muscle toning), direct clinical acceptance criteria like sensitivity/specificity are not presented. Instead, the "acceptance criteria" are compliance with established electrical safety, EMC, and biocompatibility standards, and demonstrating waveform parameters are within acceptable ranges and comparable to predicate devices.
| Acceptance Criteria Category | Specific Standard/Guidance | Subject Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 and IEC 60601-2-10 | Complies with IEC 60601-1 and IEC 60601-2-10 standards. Key parameters include: |
- Method of Line Current Isolation: Type BF Applied Part
- Patient Leakage Current: NC SFC (no specific value, but implicit compliance)
- Average DC current through electrodes (device on, no pulses):
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).