The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Models Lynx And Panther Motorized Scooters.
Device ID | K992052 |
510k Number | K992052 |
Device Name: | MODELS LYNX AND PANTHER MOTORIZED SCOOTERS |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll INVACARE CORP. ONE INVACARE WAY 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 | 1999-06-18 |
Decision Date | 1999-08-12 |
Summary: | summary |