The following data is part of a premarket notification filed by Otto Bock Health Care, Lp with the FDA for Powered Wheelchair, Model B-500.
| Device ID | K041208 |
| 510k Number | K041208 |
| Device Name: | POWERED WHEELCHAIR, MODEL B-500 |
| Classification | Wheelchair, Powered |
| Applicant | OTTO BOCK HEALTH CARE, LP 2 CARLSON PWY. STE. 100 Minneapolis, MN 55447 -4467 |
| Contact | Bob Clarke |
| Correspondent | Bob Clarke OTTO BOCK HEALTH CARE, LP 2 CARLSON PWY. STE. 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 | 2004-05-10 |
| Decision Date | 2004-10-01 |
| Summary: | summary |