Cleared Traditional

BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE

K040054 · Theodore Barash · General Hospital

Apr 2004

Decision

106d

Days

Class 1

Risk

About This 510(k) Submission

K040054 is an FDA 510(k) clearance for the BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE, a Bandage, Elastic (Class I — General Controls, product code FQM), submitted by Theodore Barash (Delray Beach, US). The FDA issued a Cleared decision on April 27, 2004, 106 days after receiving the submission on January 12, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number	K040054 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 2004
Decision Date	April 27, 2004
Days to Decision	106 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF