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Accufit

by Mettler Electronics Corporation 2 variants

510(k) K223802

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223802 Date6 Oct 2023ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

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

The Accufit is a Physical Medicine Device (Product Code IPF) designed for muscle reeducation and stimulation therapy. It delivers electrical impulses to facilitate neuromuscular recovery, aiding in rehabilitation and pain management. The device incorporates two waveform configurations derived from a predecessor model, ensuring compatibility with established therapeutic protocols. Its classification as a Class 2 device reflects its role in controlled, evidence-based clinical applications.

The Accufit is supplied as a reusable medical device, intended for use in clinical settings such as physical therapy or rehabilitation centers. It is not described as sterile or single-use, and no MRI safety information is provided in the regulatory data. The device was cleared via the Traditional 510(k) pathway (K223802) under the FDA’s Physical Medicine advisory committee, with a decision date of October 6, 2023. No additional regulatory markings (e.g., CE) or third-party certifications are mentioned in the available documentation.

Similar devices

Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).

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