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Accufit

by Mettler Electronics Corporation 2 variants

510(k) K233926

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 NumberK233926 Date21 Mar 2024ClearedStatusActive

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  • Withdrawn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. It delivers controlled electrical impulses to facilitate neuromuscular recovery, aiding in the rehabilitation of muscle function following injury, surgery, or neurological conditions. The device incorporates two waveforms derived from the predecessor Mettler Sys*Stim ME240, ensuring compatibility with established therapeutic protocols. Its classification as a Class 2 device reflects its role in non-invasive physical medicine applications under FDA oversight.

The Accufit is supplied as a reusable medical device intended for clinical use in physical therapy or rehabilitation settings. It requires proper sterilization and maintenance per manufacturer guidelines to ensure safety and efficacy. The device is not labeled as MRI-safe or unsafe, and its operation does not involve single-use consumables. Authorized under FDA 510(k) clearance (K233926) via the Traditional pathway, it adheres to regulatory standards for Physical Medicine devices. Storage and handling must comply with the manufacturer’s instructions to preserve functionality and performance.

Devices cleared under K233926

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K233926
UDI-DISize and differences
accufit
METTLER ELECTRONICS CORP.
accufit00816864021682 —On the market

Similar devices

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

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