FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WRIST SPLING & FOREARM SPLINT
K Number: K823165
·
Decision Nov 16, 1982
Classifications
1
FEI Numbers
425
Registration Numbers
425
Same Product Code
35
Applicant Total
24
Review Days
22
Basic Information
- Device Name
- WRIST SPLING & FOREARM SPLINT
- K Number
- K823165
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- WARM & FORM, ORTHOPEDIC MATERIALS
- Date Received
- October 25, 1982
- Decision Date
- November 16, 1982
- Product Code
- ILH
- 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 |
|---|---|---|---|
| ILH | Splint, Hand, And Components | FDA class 1 | Physical Medicine |
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Other Clearances by WARM & FORM, ORTHOPEDIC MATERIALS
| K Number | Device Name | ||
|---|---|---|---|
| K830245 | HEAD HALTER | Mar 9, 1983 | Substantially Equivalent |
| K830244 | TRACTION ACCESSORIES | Mar 9, 1983 | Substantially Equivalent |
| K830243 | ABDUCTION PILLOW | Mar 8, 1983 | Substantially Equivalent |
| K830246 | CAST SHOE, CAST BOOT | Feb 18, 1983 | Substantially Equivalent |
| K823658 | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | Dec 30, 1982 | Substantially Equivalent |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | Dec 30, 1982 | Substantially Equivalent |
| K823667 | CERVICAL COLLAR | Dec 30, 1982 | Substantially Equivalent |
| K823664 | UNIVERSAL SLING, SLING & SWATHE | Dec 30, 1982 | Substantially Equivalent |
| K823661 | CLAVICLE SUPPORT | Dec 30, 1982 | Substantially Equivalent |
| K823663 | ABDOMINAL BINDER | Dec 30, 1982 | Substantially Equivalent |