The following data is part of a premarket notification filed by Numotech, Inc. with the FDA for Total Contact Seat Ripple System.
Device ID | K943433 |
510k Number | K943433 |
Device Name: | TOTAL CONTACT SEAT RIPPLE SYSTEM |
Classification | Bed, Flotation Therapy, Powered |
Applicant | NUMOTECH, INC. 7946 AJAY DR. Sun Valley, CA 91352 |
Contact | Joseph A Sember |
Correspondent | Joseph A Sember NUMOTECH, INC. 7946 AJAY DR. Sun Valley, CA 91352 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-15 |
Decision Date | 1995-07-31 |