The following data is part of a premarket notification filed by Otto Bock Healthcare, Lp with the FDA for Skippi Powered Wheelchair For Children.
| Device ID | K070318 |
| 510k Number | K070318 |
| Device Name: | SKIPPI POWERED WHEELCHAIR FOR CHILDREN |
| Classification | Wheelchair, Powered |
| Applicant | OTTO BOCK HEALTHCARE, LP 2 CARLSON PKWY. N., SUITE 100 Minneapolis, MN 55447 |
| Contact | Shannon Tufvander |
| Correspondent | Shannon Tufvander OTTO BOCK HEALTHCARE, LP 2 CARLSON PKWY. N., 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 | 2007-02-02 |
| Decision Date | 2007-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04032767402533 | K070318 | 000 |
| 04032767048700 | K070318 | 000 |
| 04032767048243 | K070318 | 000 |