The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Invacare 3g Tarsys.
| Device ID | K033819 |
| 510k Number | K033819 |
| Device Name: | INVACARE 3G TARSYS |
| Classification | Wheelchair, Powered |
| Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44035 -4190 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44035 -4190 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-09 |
| Decision Date | 2004-06-04 |
| Summary: | summary |