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Figuretrim

by Jay-Mar INternational Enterprises, IN

510(k) K780730

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780730 Date9 May 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
ISB
Device Class
Class II
Regulation
21 CFR Part 890.1850
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 device is a Stimulator, Muscle, Diagnostic, as classified under regulation number 890.1850 and identified by the product code ISB. It is a diagnostic muscle stimulator used in the field of Physical Medicine.

It was cleared through the FDA 510(k) process under K780730 by Jay-Mar International Enterprises, IN, with a decision of Substantially Equivalent on May 9, 1978. The device is classified as Class II and is intended for use in diagnostic muscle stimulation within physical medicine settings.

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 FIGURETRIM device used for?

    The FIGURETRIM is a diagnostic muscle stimulator intended for use in physical medicine settings to evaluate muscle response through electrical stimulation, as classified under regulation 890.1850 and product code ISB.

  • How was the FIGURETRIM device cleared for market?

    The FIGURETRIM was cleared through the FDA 510(k) process under submission K780730 by Jay-Mar International Enterprises, IN, with a determination of Substantially Equivalent on May 9, 1978, following a traditional review.

  • What regulatory classification does the FIGURETRIM have?

    The FIGURETRIM is classified as a Class II medical device by the FDA, based on its product code ISB and regulation number 890.1850, which governs diagnostic muscle stimulators in physical medicine.