The following data is part of a premarket notification filed by Freerider Usa, Inc. with the FDA for Freerider, Model Fr168-4.
Device ID | K971388 |
510k Number | K971388 |
Device Name: | FREERIDER, MODEL FR168-4 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | FREERIDER USA, INC. 2322 DOUGLAS DR. Eugene, OR 97405 |
Contact | Robert S Mcquate |
Correspondent | Robert S Mcquate FREERIDER USA, INC. 2322 DOUGLAS DR. Eugene, OR 97405 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-14 |
Decision Date | 1997-07-23 |
Summary: | summary |