The following data is part of a premarket notification filed by Otto Bock Health Care, Lp with the FDA for Sensor Walk.
| Device ID | K052771 |
| 510k Number | K052771 |
| Device Name: | SENSOR WALK |
| Classification | Orthosis, Limb Brace |
| Applicant | OTTO BOCK HEALTH CARE, LP 2 CARLSON PWY. STE. 100 Minneapolis, MN 55447 -4467 |
| Contact | Bill Clover |
| Correspondent | Bill Clover OTTO BOCK HEALTH CARE, LP 2 CARLSON PWY. STE. 100 Minneapolis, MN 55447 -4467 |
| Product Code | IQI |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2006-05-03 |
| Summary: | summary |