The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Tri-rolls Rear Wheel Drive Powered Scooter.
| Device ID | K901586 |
| 510k Number | K901586 |
| Device Name: | TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | James R Thaler |
| Correspondent | James R Thaler INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-04 |
| Decision Date | 1990-04-16 |