FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ICE BAND
K Number: K771002
·
Decision Aug 30, 1977
Classifications
1
FEI Numbers
467
Registration Numbers
468
Same Product Code
26
Applicant Total
4
Review Days
89
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
- ICE BAND
- K Number
- K771002
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5700
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Norcliff Thayer, Inc.
- Date Received
- June 2, 1977
- Decision Date
- August 30, 1977
- Product Code
- IME
- 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 |
|---|---|---|---|
| IME | Pack, Hot Or Cold, Reusable | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IME), ordered by most recent decision date.
COLD PACK
FDA 510(k)
FDA Class 1
·Physical Medicine
HOTPAD
FDA 510(k)
FDA Class 1
·Physical Medicine
HOT OR COLD PACK (THERMIPAQ)
FDA 510(k)
FDA Class 1
·Physical Medicine
MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS
FDA 510(k)
FDA Class 1
·Physical Medicine
SUBOCCIPITAL ICE PILLOW
FDA 510(k)
FDA Class 1
·Physical Medicine
RE-HEATER, HOT PACK
FDA 510(k)
FDA Class 1
·Physical Medicine