The following data is part of a premarket notification filed by Raye's, Inc. with the FDA for Overlander Pev 2000.
Device ID | K983497 |
510k Number | K983497 |
Device Name: | OVERLANDER PEV 2000 |
Classification | Wheelchair, Powered |
Applicant | RAYE'S, INC. 204 WEST 2ND ST. P.O. BOX 320 Ellis, KS 67637 |
Contact | Willard L Frickey |
Correspondent | Willard L Frickey RAYE'S, INC. 204 WEST 2ND ST. P.O. BOX 320 Ellis, KS 67637 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-05 |
Decision Date | 1999-06-27 |