FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK
K Number: K852604
·
Decision Aug 12, 1985
Classifications
1
FEI Numbers
259
Registration Numbers
259
Same Product Code
41
Applicant Total
4
Review Days
54
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK
- K Number
- K852604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5740
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Clairol, Inc.
- Date Received
- June 19, 1985
- Decision Date
- August 12, 1985
- Product Code
- IRT
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IRT | Pad, Heating, Powered | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IRT), ordered by most recent decision date.
bite away two
FDA 510(k)
FDA Class 2
·Physical Medicine
bite away neo
FDA 510(k)
FDA Class 2
·Physical Medicine
Bite Away
FDA 510(k)
FDA Class 2
·Physical Medicine
Heated Eye Pad
FDA 510(k)
FDA Class 2
·Physical Medicine
AVACEN 100
FDA 510(k)
FDA Class 2
·Physical Medicine
FIR HEAT THERAPHY SYSYEMS
FDA 510(k)
FDA Class 2
·Physical Medicine