The following data is part of a premarket notification filed by Otto Bock Healthcare, Lp with the FDA for Z10 Wheelchair Push And Brake Assist Device.
| Device ID | K111278 |
| 510k Number | K111278 |
| Device Name: | Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE |
| Classification | Wheelchair, Powered |
| Applicant | OTTO BOCK HEALTHCARE, LP TWO CARLSON PARKWAY NORTH SUITE 100 Minneapolis, MN 55447 -4467 |
| Contact | William Kabitz |
| Correspondent | William Kabitz OTTO BOCK HEALTHCARE, LP TWO CARLSON PARKWAY NORTH 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 | 2011-05-05 |
| Decision Date | 2011-09-16 |
| Summary: | summary |