Cleared Traditional

HYDRO-THERO PAD

K841697 · Maddak, Inc. · Physical Medicine

May 1984

Decision

16d

Days

Class 2

Risk

About This 510(k) Submission

K841697 is an FDA 510(k) clearance for the HYDRO-THERO PAD, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984, 16 days after receiving the submission on April 23, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number	K841697 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 1984
Decision Date	May 09, 1984
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—