Cleared Traditional

HP-20, 30, 40, 50 & 60

K841100 · Associated Mills, Inc. · Physical Medicine

Mar 1984

Decision

10d

Days

Class 2

Risk

About This 510(k) Submission

K841100 is an FDA 510(k) clearance for the HP-20, 30, 40, 50 & 60, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by Associated Mills, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984, 10 days after receiving the submission on March 13, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number	K841100 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 1984
Decision Date	March 23, 1984
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—