Cleared Traditional

K223802 - accufit (FDA 510(k) Clearance)

K223802 · Mettler Electronics Corporation · Physical Medicine device

Oct 2023

Decision

291d

Days

Class 2

Risk

K223802 is an FDA 510(k) clearance for the accufit. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Mettler Electronics Corporation (Anaheim, US). The FDA issued a Cleared decision on October 6, 2023, 291 days after receiving the submission on December 19, 2022.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K223802 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 19, 2022
Decision Date	October 06, 2023
Days to Decision	291 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF