The following data is part of a premarket notification filed by Vestil Manufacturing Corp. with the FDA for Karma Discovery, Model Kp40.
Device ID | K014127 |
510k Number | K014127 |
Device Name: | KARMA DISCOVERY, MODEL KP40 |
Classification | Wheelchair, Powered |
Applicant | VESTIL MANUFACTURING CORP. 900 GROWTH PKWY. Angola, IN 46703 |
Contact | Rich Michael |
Correspondent | Rich Michael VESTIL MANUFACTURING CORP. 900 GROWTH PKWY. Angola, IN 46703 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-17 |
Decision Date | 2002-03-15 |
Summary: | summary |