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K Number
K980346
Device Name
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
Manufacturer
UNIVERSAL TECHNOLOGY SYSTEMS, INC.
Date Cleared
1998-04-28

(90 days)

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

1.Relaxation of muscle spasms;

2.prevention or retardation of disuse atrophy;

3.increasing local blood circulation;

4.muscle re-education;

5.immediate postsurgical stimulation of calf muscles to prevent venous thrombosis; and

  1. Maintaining or increasing range of motion.
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a device called the "UTS Electrical Muscle Stimulation Device - PGS 4000". It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical or performance study report.

Therefore, I cannot provide the requested information in the form of a table or detailed answers because the input text does not contain these details.

Here's a breakdown of why the information is missing:

  • Type of Document: This is an FDA clearance letter, which acknowledges substantial equivalence, rather than a detailed performance study report. It focuses on regulatory approval based on comparison to existing devices.
  • Lack of Performance Data: The letter provides the "Indications For Use" (which one might loosely consider high-level "acceptance criteria" for what the device is intended to do), but it doesn't present specific, quantifiable performance metrics, study design, or results demonstrating that the device achieves those indications with a certain level of efficacy or safety.
  • No Study Details: There is no mention of sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

§ 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).