The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Tracer Series Manual Wheelchairs.
| Device ID | K935398 |
| 510k Number | K935398 |
| Device Name: | TRACER SERIES MANUAL WHEELCHAIRS |
| Classification | Wheelchair, Mechanical |
| Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-09 |
| Decision Date | 1994-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447103042 | K935398 | 000 |
| 00841447103035 | K935398 | 000 |