FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CASH ORTHOSIS
K Number: K812099
·
Decision Aug 13, 1981
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
10
Applicant Total
1
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
- CASH ORTHOSIS
- K Number
- K812099
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- David Hendricks, C.P.O.
- Date Received
- July 24, 1981
- Decision Date
- August 13, 1981
- Product Code
- IPY
- 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 |
|---|---|---|---|
| IPY | Orthosis, Lumbo-Sacral | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPY), ordered by most recent decision date.
M-BRACE
FDA 510(k)
FDA Class 1
·Physical Medicine
LUMBOSACRAL SUPPORT
FDA 510(k)
FDA Class 1
·Physical Medicine
CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS
FDA 510(k)
FDA Class 1
·Physical Medicine
LUMBO-SACRAL FLEXION ORTHOSIS
FDA 510(k)
FDA Class 1
·Physical Medicine
LUMBAR FLEXION BRACE
FDA 510(k)
FDA Class 1
·Physical Medicine
SPINAL EXTENSION BRACE
FDA 510(k)
FDA Class 1
·Physical Medicine