K800716 is an FDA 510(k) clearance for the ORTHOTIC LEG GAIT CORRECTOR DEVICE. This device is classified as a Twister, Brace Setting (Class I - General Controls, product code ITO).
Submitted by Ipos Luneburg (Mchenry, US). The FDA issued a Cleared decision on May 2, 1980, 32 days after receiving the submission on March 31, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3410.
| 510(k) Number | K800716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1980 |
| Decision Date | May 02, 1980 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ITO — Twister, Brace Setting |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3410 |