The following data is part of a premarket notification filed by Convaid Products Llc. with the FDA for Convaid Flyer Fl12, Fl13, Fl14, Fl15 And Fl16; Convaid Flyer Transit Fl12t, Fl13t, Fl14t, Fl15t And Fl16t.
Device ID | K171017 |
510k Number | K171017 |
Device Name: | Convaid Flyer FL12, FL13, FL14, FL15 And FL16; Convaid Flyer Transit FL12T, FL13T, FL14T, FL15T And FL16T |
Classification | Wheelchair, Mechanical |
Applicant | Convaid Products Llc. 2830 California St Torrance, CA 90503 |
Contact | Donald Griggs |
Correspondent | Donald Griggs Convaid Products Llc. 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 | 2017-04-05 |
Decision Date | 2017-10-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10840117400105 | K171017 | 000 |
10840117407388 | K171017 | 000 |
10840117407364 | K171017 | 000 |
10840117406602 | K171017 | 000 |
10840117406589 | K171017 | 000 |