(182 days)
EMS is used for:
- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increasing local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
eMVFit has MULTI handpiece, EMS handpiece, patient switch, cradle, distilled water injection hose & funnel, key switch and power cable.
eMVFit has a user interface including an LCD touch screen and has MULTI mode and EMS mode. MULTI mode has RF and EMS functions that use the MULTI handpiece.
In the case of RF, the target temperature can be set and a vacuum can be used together, and a cooling function can be used as a safety system to prevent burns on the skin surface.
In addition, the MULTI handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43 ℃.
EMS mode has an EMS function that uses the EMS handpiece.
The provided text is a 510(k) Summary for the eMVFit (MVF-10M) device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices through various comparisons and non-clinical performance data.
However, the document does not contain information on acceptance criteria for a study demonstrating device performance in terms of clinical outcomes, nor does it describe a study involving human subjects or expert readers to prove the device meets specific acceptance criteria for diagnostic or clinical effectiveness.
The document primarily details:
- Device Description and Indications for Use: What the device is and what it's used for (muscle spasms, disuse atrophy, circulation, re-education, range of motion, DVT prevention).
- Predicate Device Comparison: A detailed table comparing the eMVFit's technical specifications (electrical parameters, dimensions, operation modes) with three predicate devices (INMODE LTD.'s Evolve System with T3 and Tone Applicators, and TimeWaver Production GmbH's TimeWaver Frequency).
- Substantial Equivalence Discussion: Explains that differences between the subject device and predicates do not raise new questions of safety or effectiveness, often citing compliance with IEC standards.
- Non-Clinical (Bench) Performance Data: Lists a series of standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 60601-1-6, ISO 10993-10, ISO 10993-23, IEC 62304) to which the device was tested to demonstrate basic safety, essential performance, EMC, risk management, usability, biocompatibility, and software functions. It states the device passed all testing.
Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance (in the context of clinical outcomes), sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The document describes technical compliance and safety testing against engineering standards, not direct clinical performance or effectiveness studies with human data or expert evaluations. The "performance data" referred to is "Non-Clinical (Bench) Performance Data," meaning lab tests, not clinical trials.
The FDA's 510(k) pathway often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical efficacy studies, especially for devices with well-understood mechanisms of action like muscle stimulators. The information provided aligns with this regulatory pathway.
§ 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).