FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IPOS ANTI-ADDUCTUS SHOE
K Number: K831690
·
Decision Jun 24, 1983
Classifications
1
FEI Numbers
203
Registration Numbers
203
Same Product Code
6
Applicant Total
8
Review Days
31
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Basic Information
- Device Name
- IPOS ANTI-ADDUCTUS SHOE
- K Number
- K831690
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Ipos Luneburg
- Date Received
- May 24, 1983
- Decision Date
- June 24, 1983
- Product Code
- KNP
- 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 |
|---|---|---|---|
| KNP | Orthosis, Corrective Shoe | FDA class 1 | Physical Medicine |
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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 |
| K802977 | IPOCARBON STRETCH STOCKINETTE | Dec 19, 1980 | Substantially Equivalent |
| K802976 | CARBONACRYL | Dec 19, 1980 | Substantially Equivalent |
| K800749 | IPOCON 7 | Jul 28, 1980 | Substantially Equivalent |
| K800716 | ORTHOTIC LEG GAIT CORRECTOR DEVICE | May 2, 1980 | Substantially Equivalent |
| K800715 | OHC DYNAMIC CLUB FOOT BRACE | May 2, 1980 | Substantially Equivalent |