Cleared Traditional

K940301 - COMPEX 2 (FDA 510(k) Clearance)

K940301 · Biodex Medical Systems, Inc. · Physical Medicine device

Dec 1994

Decision

338d

Days

Class 2

Risk

K940301 is an FDA 510(k) clearance for the COMPEX 2. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Biodex Medical Systems, Inc. (Shirley, US). The FDA issued a Cleared decision on December 28, 1994, 338 days after receiving the submission on January 24, 1994.

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

Submission Details

510(k) Number	K940301 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	January 24, 1994
Decision Date	December 28, 1994
Days to Decision	338 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—