FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAND-AGE ICE-BANDAGE
K Number: K761254
·
Decision Feb 24, 1977
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
19
Review Days
73
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
- BAND-AGE ICE-BANDAGE
- K Number
- K761254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Surgicot, Inc.
- Date Received
- December 13, 1976
- Decision Date
- February 24, 1977
- Product Code
- ILO
- 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILO), ordered by most recent decision date.
Armory Motion
FDA 510(k)
FDA Class 2
·Physical Medicine
COOLSKIN
FDA 510(k)
FDA Class 2
·Physical Medicine
T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
FDA 510(k)
FDA Class 2
·Physical Medicine
JUNIPER CLN1 DERMAL COOLING DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO POLAR CARE 500
FDA 510(k)
FDA Class 2
·Physical Medicine
IVC SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Surgicot, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962605 | PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) | Mar 11, 1997 | Substantially Equivalent |
| K931270 | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER | Apr 13, 1994 | Substantially Equivalent |
| K863122 | ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. | Dec 17, 1986 | Substantially Equivalent |
| K855101 | ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR | Jul 17, 1986 | Substantially Equivalent |
| K854631 | ASSERT EO BIOLOGICAL TEST PACK | May 27, 1986 | Substantially Equivalent |
| K854902 | SURGICOT STEAM TEST PACK | May 20, 1986 | Substantially Equivalent |
| K840541 | NEURO SPONGE | Apr 23, 1984 | Substantially Equivalent |
| K840471 | EYE SPEAR | Mar 16, 1984 | Substantially Equivalent |
| K840470 | SURGISCRIBE MARKING PEN | Mar 12, 1984 | Substantially Equivalent |
| K830739 | PRO-GUARD | Mar 29, 1983 | Substantially Equivalent |