The following data is part of a premarket notification filed by Nissin Medical Inc. with the FDA for Nissin Pediatric Series Wheelchair.
| Device ID | K063521 |
| 510k Number | K063521 |
| Device Name: | NISSIN PEDIATRIC SERIES WHEELCHAIR |
| Classification | Chair, With Casters |
| Applicant | NISSIN MEDICAL INC. 3551 VOYAGER COURT, STE 102 Torrance, CA 90503 |
| Contact | Takahiro Haruyama |
| Correspondent | Takahiro Haruyama NISSIN MEDICAL INC. 3551 VOYAGER COURT, STE 102 Torrance, CA 90503 |
| Product Code | INM |
| CFR Regulation Number | 890.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-22 |
| Decision Date | 2007-02-05 |
| Summary: | summary |