(484 days)
WIEMSPRO is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSPRO is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
WIEMSPRO electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances.
WIEMSPRO is a device with electronic muscle stimulation based on EMS technology. Reqarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitationpurposes.
This document is an FDA 510(k) summary for a powered muscle stimulator called "WIEMSPRO." It's a regulatory submission, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance results from a study, sample sizes, expert ground truth establishment, or clinical study details.
The document explicitly states:
- "No clinical studies provided."
- "We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE):"
- "0. General information of both devices is the same"
- "1. Intended use and indications/principle of operations of both devices are the same."
- "2. There are no differences in the technological characteristic/performance data of the proposed device and those of the predicate device. Thus, the SE is not affected."
- The comparison table (pages 4-5) lists technical specifications and notes "Same" for almost all characteristics between the original WIEMSPRO (K181955) and the "Modified Device" WIEMSPRO (K211298), except for the software version which is "Similar."
This 510(k) submission relies on demonstrating substantial equivalence to a previously cleared predicate device (K181955) by showing that the new device has the same intended use, indications for use, and similar technological characteristics, and that any minor differences do not raise new questions of safety or effectiveness. It does not present new performance data from a specific study designed to meet acceptance criteria through statistical testing.
Therefore, it's not possible to fill out the requested table or answer the questions based on the provided text, as this type of information is typically found in a clinical study report or a different section of a more comprehensive 510(k) submission if new performance data were required.
§ 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).