510(k) K852604

MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK by Clairol, Inc. — Product Code IRT

K852604 is an FDA 510(k) premarket notification submitted by Clairol, Inc. for the device "MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK". The FDA issued a decision of Substantially Equivalent on August 12, 1985. The device falls under product code IRT (Pad, Heating, Powered), a Class II device regulated under 21 CFR 890.5740. Clairol, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1985
Date Received
June 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Heating, Powered
Device Class
Class II
Regulation Number
890.5740
Review Panel
PM
Submission Type