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Power Trainer With Neuromuscular Stimulation

by Sinties Scientific, Inc.

510(k) K904509

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904509 Date12 Feb 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Power Trainer With Neuromuscular Stimulation is a muscle stimulator that provides neuromuscular stimulation. It is classified as a powered muscle stimulator and is used in the field of physical medicine.

The device is supplied with FDA 510K authorizations, specifically with clearance type Traditional and product code IPF. It was cleared on February 12, 1992, with a decision description of Substantially Equivalent. The device has a specific K number, K904509, and is classified as a class 2 device.

Other devices from Sinties Scientific, Inc.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Power Trainer With Neuromuscular Stimulation used for?

    The Power Trainer With Neuromuscular Stimulation is used in the field of physical medicine to provide neuromuscular stimulation.

  • What kind of authorizations does the device have?

    The device has FDA 510K authorizations with a clearance type of Traditional and product code IPF.

  • Is the Power Trainer With Neuromuscular Stimulation a single-use or reusable device?

    The device description does not specify whether it is single-use or reusable, but it is classified as a powered muscle stimulator.