Cleared Traditional

BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)

K071710 · Johnson & Johnson Consumer Products, Inc. · Physical Medicine

Aug 2007

Decision

53d

Days

Class 1

Risk

About This 510(k) Submission

K071710 is an FDA 510(k) clearance for the BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS), a Pack, Hot Or Cold, Disposable (Class I — General Controls, product code IMD), submitted by Johnson & Johnson Consumer Products, Inc. (Morris Plains, US). The FDA issued a Cleared decision on August 14, 2007, 53 days after receiving the submission on June 22, 2007. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number	K071710 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2007
Decision Date	August 14, 2007
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF