The following data is part of a premarket notification filed by Hoveround Corp. with the FDA for Hoverround Teknique.
Device ID | K122707 |
510k Number | K122707 |
Device Name: | HOVERROUND TEKNIQUE |
Classification | Wheelchair, Powered |
Applicant | HOVEROUND CORP. 2151 WHITFIELD INDUSTRIAL WAY Sarasota, FL 34243 |
Contact | Robert Munch |
Correspondent | Robert Munch HOVEROUND CORP. 2151 WHITFIELD INDUSTRIAL WAY Sarasota, FL 34243 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-04 |
Decision Date | 2013-05-07 |