FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUSPENDER ORTHOPEDIC SUSPENSION DEVICE
K Number: K860037
·
Decision Jan 21, 1986
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
37
Applicant Total
4
Review Days
15
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Basic Information
- Device Name
- SUSPENDER ORTHOPEDIC SUSPENSION DEVICE
- K Number
- K860037
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5850
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Comfortex, Inc.
- Date Received
- January 6, 1986
- Decision Date
- January 21, 1986
- Product Code
- HST
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HST | Apparatus, Traction, Non-Powered | FDA class 1 | Orthopedic |
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