The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare Topaz Bariatric Manual Wheelchair.
| Device ID | K060582 |
| 510k Number | K060582 |
| Device Name: | INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | INVACARE CORPORATION ONE INVACARE WAY Elyria, OH 44035 -4190 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin INVACARE CORPORATION ONE INVACARE WAY Elyria, OH 44035 -4190 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-07 |
| Decision Date | 2006-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447102816 | K060582 | 000 |