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accufit

by Mettler Electronics Corp.

accufit is a Class II device made by Mettler Electronics Corp., cleared under FDA 510(k) K233926 on 21 Mar 2024 and listed in FDA GUDID since 22 Apr 2026 (UDI-DI 00816864021682), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K233926

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816864021682 UDI-DI Date22 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233926 Date21 Mar 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233926 decided 21 Mar 2024 Active
  • FDA GUDID UDI-DI 00816864021682 listed 22 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233926
  2. Listed FDA GUDID 00816864021682

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
accufit
Primary DI / UDI-DI
00816864021682
510(k) Number
FDA product code
IPF
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
890.5850
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Mettler Electronics Corp.

See all devices from Mettler Electronics Corp. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)