The following data is part of a premarket notification filed by Wheelchairs Of Kansas with the FDA for Mighty Air.
Device ID | K974319 |
510k Number | K974319 |
Device Name: | MIGHTY AIR |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | WHEELCHAIRS OF KANSAS P.O. BOX 320 204 W. 2ND ST. Ellis, KS 67637 |
Contact | Lee Frickey |
Correspondent | Lee Frickey WHEELCHAIRS OF KANSAS P.O. BOX 320 204 W. 2ND ST. Ellis, KS 67637 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-17 |
Decision Date | 1998-01-22 |