The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Kuschall Champion, Kuschall Compact, Kuschall Ultra-light.
| Device ID | K041072 |
| 510k Number | K041072 |
| Device Name: | KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT |
| Classification | Wheelchair, Mechanical |
| Applicant | INVACARE CORPORATION ONE INVACARE WAY Elyria, OH 44035 -4190 |
| Contact | Carroll L Martin |
| Correspondent | Carroll L Martin INVACARE CORPORATION ONE INVACARE WAY Elyria, OH 44035 -4190 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-26 |
| Decision Date | 2004-05-12 |
| Summary: | summary |