FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEAD HALTER
K Number: K830245
·
Decision Mar 9, 1983
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
14
Applicant Total
24
Review Days
43
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Basic Information
- Device Name
- HEAD HALTER
- K Number
- K830245
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5925
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Warm & Form, Orthopedic Materials
- Date Received
- January 25, 1983
- Decision Date
- March 9, 1983
- Product Code
- ILZ
- 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 |
|---|---|---|---|
| ILZ | Accessories, Traction | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILZ), ordered by most recent decision date.
FLEXION DISTRATION SUPPORT
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VIBRA-TRAC TRACTION TABLE
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AMX-110, AMX-II AND AMX-III
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VECTOR BAR SUSPENSION/TRACTION UNIT
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TRACTION ACCESSORIES
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SAUNDERS #7080 CERVICAL TRACTION SYS
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 |
| K830243 | ABDUCTION PILLOW | Mar 8, 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 |