K052771 is an FDA 510(k) clearance for the SENSOR WALK. This device is classified as a Orthosis, Limb Brace (Class I - General Controls, product code IQI).
Submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on May 3, 2006, 215 days after receiving the submission on September 30, 2005.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K052771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2005 |
| Decision Date | May 03, 2006 |
| Days to Decision | 215 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IQI - Orthosis, Limb Brace |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3475 |