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K Number
K022175
Device Name
P4 PHYSIO
Manufacturer
VALMED CORP.
Date Cleared
2002-09-09

(68 days)

Product Code
IPF,IPG
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Electrical Muscle Stimulator (EMS) devices should only be used under advice from physician or a qualified health professional as adjunctive therapy for the treatment of medical conditions. The intended application is for stimulation of all parts of a body except head and frontal part of the neck. Specific applications include:

  • Relaxation of muscle spasms
  • Prevention or retardation of disuse atrophy;
  • Increasing local blood circulation;
  • Muscle re-education;
  • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
  • Maintaining or increasing range of motion of extremities.
Device Description

Powered Muscle Stimulator

AI/ML Overview

This document indicates a 510(k) clearance for a P4-PHYSIO Powered Muscle Stimulator. The document does not describe acceptance criteria or a study proving that the device meets acceptance criteria. It focuses on the substantial equivalence determination for the device based on its indications for use. Therefore, I cannot provide the requested information from the given text.

§ 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).