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K Number
K020130
Device Name
ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
Manufacturer
ROLOR ELECTRONICS CORP.
Date Cleared
2002-12-02

(321 days)

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

Specific indications: used to apply an electrical current to electrodes on a patient's skin to function as: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy Increasing local blood circulation. Maintaining or increasing range of motion.

Device Description

ROLOR POWERED MUSLCE STIMULATOR GP-8016M

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a powered muscle stimulator. It does not contain any information about acceptance criteria, study details, or device performance data. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

The document primarily focuses on:

  • The FDA's determination of substantial equivalence for the "ROLOR POWERED MUSCLE STIMULATOR GP-8016M".
  • The classification of the device (Class II - Product Code: IPF).
  • General regulatory requirements for the device.
  • The intended use of the device, which includes relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion.

No performance data, study designs, sample sizes, expert qualifications, or ground truth methodologies are mentioned.

§ 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).