The following data is part of a premarket notification filed by Otto Bock Healthcare, Lp with the FDA for Discovery Tmax Manual Wheelchair.
| Device ID | K113164 |
| 510k Number | K113164 |
| Device Name: | DISCOVERY TMAX MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | OTTO BOCK HEALTHCARE, LP 2 CARLSON PKWY. N., SUITE 100 Minneapolis, MN 55447 |
| Contact | William Kabitz |
| Correspondent | William Kabitz OTTO BOCK HEALTHCARE, LP 2 CARLSON PKWY. N., SUITE 100 Minneapolis, MN 55447 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-26 |
| Decision Date | 2013-03-11 |
| Summary: | summary |