The following data is part of a premarket notification filed by Medical Flotation Systems, Inc. with the FDA for Ultraflotation Medical Wheelchair.
Device ID | K884908 |
510k Number | K884908 |
Device Name: | ULTRAFLOTATION MEDICAL WHEELCHAIR |
Classification | Scale, Platform, Wheelchair |
Applicant | MEDICAL FLOTATION SYSTEMS, INC. 104 ELDEN ST., SUITE 11 Herndon, VA 22070 |
Contact | Jacobs, Md |
Correspondent | Jacobs, Md MEDICAL FLOTATION SYSTEMS, INC. 104 ELDEN ST., SUITE 11 Herndon, VA 22070 |
Product Code | INF |
CFR Regulation Number | 890.3940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-23 |
Decision Date | 1988-12-27 |