(120 days)
The InMode System with Tone Applicator is used in EMS mode for:
Prevention or retardation of disuse atrophy
Maintaining or increasing range of motion
Muscle re-education
Relaxation of muscle spasms
Increasing local blood circulation
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
And in TENS mode for: Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain
The InMode System in combination with Tone Applicator (manufactured by InMode Ltd.), is a versatile device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications. The InMode System with Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the front panel.
This document describes the InMode System with Tone Applicator, a powered muscle stimulator. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device (Vectra Neo Clinical Therapy System, K132284), rather than presenting a standalone study with acceptance criteria for device performance in the clinical sense (e.g., sensitivity, specificity for a diagnostic device).
Therefore, this response will reframe the "acceptance criteria" as the performance standards and safety criteria the device was tested against for regulatory clearance. The "study that proves the device meets the acceptance criteria" refers to the non-clinical (bench) performance data and compliance with recognized standards.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a powered muscle stimulator, the "acceptance criteria" revolve around demonstrating safety, electrical performance, and biocompatibility, as well as functional equivalence to the predicate device. The "reported device performance" are the results of the non-clinical tests and conformance to standards.
| Acceptance Criteria (Performance/Safety Standard) | Reported Device Performance |
|---|---|
| Electrical Safety & Essential Performance | |
| IEC 60601-1 (General Requirements for Basic Safety and Essential Performance) | Device complies with the standard. Specific safety parameters: Patient Leakage Current - Normal Condition ( |
§ 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).