The following data is part of a premarket notification filed by Convaid Products, Inc. with the FDA for Trekker, Trekker Transit.
Device ID | K140416 |
510k Number | K140416 |
Device Name: | TREKKER, TREKKER TRANSIT |
Classification | Wheelchair, Mechanical |
Applicant | CONVAID PRODUCTS, INC. 2830 CALIFORNIA ST. Torrance, CA 90503 |
Contact | Donald Griggs |
Correspondent | Donald Griggs CONVAID PRODUCTS, INC. 2830 CALIFORNIA ST. Torrance, CA 90503 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-18 |
Decision Date | 2014-09-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10840117407623 | K140416 | 000 |
10840117404882 | K140416 | 000 |