Cleared Traditional

KING SIZE HEAT PAD

K924885 · Conair Corp. · Physical Medicine
Oct 1993
Decision
379d
Days
Class 2
Risk

About This 510(k) Submission

K924885 is an FDA 510(k) clearance for the KING SIZE HEAT PAD, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on October 12, 1993, 379 days after receiving the submission on September 28, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number K924885 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1992
Decision Date October 12, 1993
Days to Decision 379 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IRT — Pad, Heating, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5740