FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHOTIC LEG GAIT CORRECTOR DEVICE
K Number: K800716
·
Decision May 2, 1980
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
0
Applicant Total
8
Review Days
32
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
- ORTHOTIC LEG GAIT CORRECTOR DEVICE
- K Number
- K800716
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3410
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Ipos Luneburg
- Date Received
- March 31, 1980
- Decision Date
- May 2, 1980
- Product Code
- ITO
- 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 |
|---|---|---|---|
| ITO | Twister, Brace Setting | FDA class 1 | Physical Medicine |
Other Clearances by Ipos Luneburg
| K Number | Device Name | ||
|---|---|---|---|
| K834143 | NYLON COMPRESSION STUMP SHEATH | Jan 9, 1984 | Substantially Equivalent |
| K833868 | IPOS G.L.P. SYSTEM | Nov 28, 1983 | Substantially Equivalent |
| K831690 | IPOS ANTI-ADDUCTUS SHOE | Jun 24, 1983 | Substantially Equivalent |
| K802977 | IPOCARBON STRETCH STOCKINETTE | Dec 19, 1980 | Substantially Equivalent |
| K802976 | CARBONACRYL | Dec 19, 1980 | Substantially Equivalent |
| K800749 | IPOCON 7 | Jul 28, 1980 | Substantially Equivalent |
| K800715 | OHC DYNAMIC CLUB FOOT BRACE | May 2, 1980 | Substantially Equivalent |