FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABDUCTION PILLOW
K Number: K830243
·
Decision Mar 8, 1983
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
3
Applicant Total
24
Review Days
42
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Basic Information
- Device Name
- ABDUCTION PILLOW
- K Number
- K830243
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3665
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Warm & Form, Orthopedic Materials
- Date Received
- January 25, 1983
- Decision Date
- March 8, 1983
- Product Code
- IOZ
- 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 |
|---|---|---|---|
| IOZ | Splint, Abduction, Congenital Hip Dislocation | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IOZ), ordered by most recent decision date.
ABDUCTION PILLOW
FDA 510(k)
FDA Class 1
·Physical Medicine
HIP ABDUCTION SPLINT
FDA 510(k)
FDA Class 1
·Physical Medicine
PAVLIK HARNESS
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Warm & Form, Orthopedic Materials
| K Number | Device Name | ||
|---|---|---|---|
| K830244 | TRACTION ACCESSORIES | Mar 9, 1983 | Substantially Equivalent |
| K830245 | HEAD HALTER | Mar 9, 1983 | Substantially Equivalent |
| K830246 | CAST SHOE, CAST BOOT | Feb 18, 1983 | Substantially Equivalent |
| K823659 | PELVIC TRACTION BELT | Dec 30, 1982 | Substantially Equivalent |
| K823658 | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | Dec 30, 1982 | Substantially Equivalent |
| K823660 | UNIVERSAL BUCKS TRACTION | Dec 30, 1982 | Substantially Equivalent |
| K823662 | RIB BELT (UNIVERSAL) | Dec 30, 1982 | Substantially Equivalent |
| K823664 | UNIVERSAL SLING, SLING & SWATHE | Dec 30, 1982 | Substantially Equivalent |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | Dec 30, 1982 | Substantially Equivalent |
| K823663 | ABDOMINAL BINDER | Dec 30, 1982 | Substantially Equivalent |