Orthotic Leg Gait Corrector Device
FDA 510(k) K800716 · Ipos Luneburg
510(k) numberK800716
Submission
- Device name
- Orthotic Leg Gait Corrector Device
- Applicant
- Ipos Luneburg
Mchenry, IL, US - Received
- March 31, 1980
- Decision date
- May 2, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ITO – Twister, Brace Setting
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3410
- Specialty
- Physical Medicine
More from Ipos Luneburg
| 510(k) | Device | Decision |
|---|---|---|
| K834143 | Nylon Compression Stump Sheath · Traditional | 01/09/1984SE |
| K833868 | Ipos G.L.P. SystemKFX · Traditional | 11/28/1983SE |
| 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 |
| K800715 | Ohc Dynamic Club Foot BraceIQI · Traditional | 05/02/1980SE |
Questions and answers
When was Orthotic Leg Gait Corrector Device cleared by the FDA?
Orthotic Leg Gait Corrector Device (K800716) received a 510(k) decision of Substantially Equivalent on May 2, 1980, 32 days after the submission was received.
What is the product code of K800716?
The FDA product code is ITO – Twister, Brace Setting, a Class I (low risk) device regulated under 21 CFR 890.3410.