Cleared Traditional

K002336 - MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T (FDA 510(k) Clearance)

K002336 · Apex Medical Corp. · Physical Medicine device

Jul 2001

Decision

360d

Days

Class 2

Risk

K002336 is an FDA 510(k) clearance for the MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on July 27, 2001, 360 days after receiving the submission on August 1, 2000.

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

Submission Details

510(k) Number	K002336 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 01, 2000
Decision Date	July 27, 2001
Days to Decision	360 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF