FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ICE PACK, REUSABLE FLEXIBLE
K Number: K790009
·
Decision Jan 22, 1979
Classifications
1
FEI Numbers
467
Registration Numbers
468
Same Product Code
26
Applicant Total
42
Review Days
20
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 PACK, REUSABLE FLEXIBLE
- K Number
- K790009
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5700
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Ackrad Laboratories
- Date Received
- January 2, 1979
- Decision Date
- January 22, 1979
- 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
Other Clearances by Ackrad Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K021272 | SIB CATHETER, MODEL 61-7005 | May 21, 2002 | Substantially Equivalent |
| K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY | Apr 24, 2002 | Substantially Equivalent |
| K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 | Apr 16, 2002 | Substantially Equivalent |
| K970492 | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER | Apr 9, 1997 | Substantially Equivalent |
| K961752 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Aug 8, 1996 | Substantially Equivalent |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Apr 23, 1996 | Substantially Equivalent |
| K952542 | ACKRAD ESOPHAGEAL BALLOON CATHETER SET | Apr 23, 1996 | Substantially Equivalent |
| K953034 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Aug 29, 1995 | Substantially Equivalent |
| K915813 | ACKRAD ERCP CONTRAST DELIVERY SET | Mar 11, 1992 | Substantially Equivalent |
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | Jul 1, 1991 | Substantially Equivalent |