FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IPOS G.L.P. SYSTEM
K Number: K833868
·
Decision Nov 28, 1983
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
3
Applicant Total
8
Review Days
21
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Basic Information
- Device Name
- IPOS G.L.P. SYSTEM
- K Number
- K833868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Ipos Luneburg
- Date Received
- November 7, 1983
- Decision Date
- November 28, 1983
- Product Code
- KFX
- 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 |
|---|---|---|---|
| KFX | Assembly, Thigh/Knee/Shank/Ankle/Foot, External | FDA class 2 | 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 |
| 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 |
| K800716 | ORTHOTIC LEG GAIT CORRECTOR DEVICE | May 2, 1980 | Substantially Equivalent |
| K800715 | OHC DYNAMIC CLUB FOOT BRACE | May 2, 1980 | Substantially Equivalent |