The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model Cgs Tilt Seating System For Power Wheelchairs.
| Device ID | K001777 |
| 510k Number | K001777 |
| Device Name: | MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS |
| Classification | Wheelchair, Powered |
| Applicant | INVACARE CORP. ONE INVACARE WAY Elyria, OH 44036 -2125 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll INVACARE CORP. ONE INVACARE WAY Elyria, OH 44036 -2125 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-13 |
| Decision Date | 2000-07-24 |