The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Tri-scoot Front Wheel Drive Powered Scooter.
Device ID | K900600 |
510k Number | K900600 |
Device Name: | TRI-SCOOT FRONT 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 | 1990-02-08 |
Decision Date | 1990-02-20 |