The following data is part of a premarket notification filed by Otto Bock Health Care, Lp with the FDA for C2000 Powered Wheelchair.
| Device ID | K101524 |
| 510k Number | K101524 |
| Device Name: | C2000 POWERED WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | OTTO BOCK HEALTH CARE, LP TWO CARLSON PARKWAY NORTH SUITE 100 Minneapolis, MN 55447 |
| Contact | William Kabitz |
| Correspondent | William Kabitz OTTO BOCK HEALTH CARE, LP TWO CARLSON PARKWAY NORTH SUITE 100 Minneapolis, MN 55447 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-02 |
| Decision Date | 2010-09-29 |
| Summary: | summary |