Cleared Traditional

FEMININE HEAT WRAP

K924970 · Conair Corp. · Physical Medicine
Oct 1994
Decision
733d
Days
Class 2
Risk

About This 510(k) Submission

K924970 is an FDA 510(k) clearance for the FEMININE HEAT WRAP, 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 3, 1994, 733 days after receiving the submission on September 30, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number K924970 FDA.gov
FDA Decision Cleared SN
Date Received September 30, 1992
Decision Date October 03, 1994
Days to Decision 733 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

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