Ipos G.L.P. System
FDA 510(k) K833868 · Ipos Luneburg
510(k) numberK833868
Submission
- Device name
- Ipos G.L.P. System
- Applicant
- Ipos Luneburg
Mchenry, IL, US - Received
- November 7, 1983
- Decision date
- November 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KFX – Assembly, Thigh/Knee/Shank/Ankle/Foot, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3500
- Specialty
- Physical Medicine
Other 510(k)s with product code KFX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932184 | Sterile Lemaitre Glow 'N Tell TapeKFX · Traditional | Vascutech, Inc. | 07/22/1993SE |
| K830285 | Regnell Hydraulic Femoral ProthesisKFX · Traditional | Besco Financial Service | 03/09/1983SE |
| K822240 | Ethylene Oxide Steriliz. Parametric Rel.KFX · Traditional | American Mcgaw | 12/30/1982SE |
More from American Mcgaw
| 510(k) | Device | Decision |
|---|---|---|
| K834143 | Nylon Compression Stump Sheath · Traditional | 01/09/1984SE |
| K831690 | Ipos Anti-Adductus ShoeKNP · Traditional | 06/24/1983SE |
| K802977 | Ipocarbon Stretch Stockinette · Traditional | 12/19/1980SE |
| K802976 | Carbonacryl · Traditional | 12/19/1980SE |
| K800749 | Ipocon 7ITG · Traditional | 07/28/1980SE |
| K800716 | Orthotic Leg Gait Corrector DeviceITO · Traditional | 05/02/1980SE |
| K800715 | Ohc Dynamic Club Foot BraceIQI · Traditional | 05/02/1980SE |
Questions and answers
When was Ipos G.L.P. System cleared by the FDA?
Ipos G.L.P. System (K833868) received a 510(k) decision of Substantially Equivalent on November 28, 1983, 21 days after the submission was received.
What is the product code of K833868?
The FDA product code is KFX – Assembly, Thigh/Knee/Shank/Ankle/Foot, External, a Class II (moderate risk) device regulated under 21 CFR 890.3500.