The following data is part of a premarket notification filed by Nissin Medical Industries Co., Ltd with the FDA for Nissin Series Mechanical Wheelchair.
| Device ID | K052521 |
| 510k Number | K052521 |
| Device Name: | NISSIN SERIES MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | NISSIN MEDICAL INDUSTRIES CO., LTD 15637 FOX COVE CIRCLE Moseley, VA 23120 |
| Contact | Darren Reeves |
| Correspondent | Darren Reeves NISSIN MEDICAL INDUSTRIES CO., LTD 15637 FOX COVE CIRCLE Moseley, VA 23120 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-14 |
| Decision Date | 2005-09-26 |
| Summary: | summary |