The following data is part of a premarket notification filed by Otto Bock Healthcare, Lp with the FDA for A-200 Powered Wheelchair.
| Device ID | K052706 |
| 510k Number | K052706 |
| Device Name: | A-200 POWERED WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | OTTO BOCK HEALTHCARE, LP 2 CARLSON PKWY., SUITE 100 Minneapolis, MN 55447 -4467 |
| Contact | Bob Clarke |
| Correspondent | Bob Clarke OTTO BOCK HEALTHCARE, LP 2 CARLSON PKWY., SUITE 100 Minneapolis, MN 55447 -4467 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2005-12-27 |
| Summary: | summary |