The following data is part of a premarket notification filed by Wireless Medcare, Llc with the FDA for Vivatrak.
| Device ID | K101109 |
| 510k Number | K101109 |
| Device Name: | VIVATRAK |
| Classification | Monitor, Bed Patient |
| Applicant | WIRELESS MEDCARE, LLC 1733 CANTON LANE Marietta, GA 30062 |
| Contact | Paul Sumner |
| Correspondent | Paul Sumner WIRELESS MEDCARE, LLC 1733 CANTON LANE Marietta, GA 30062 |
| Product Code | KMI |
| CFR Regulation Number | 880.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-20 |
| Decision Date | 2010-07-15 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VIVATRAK 77850211 4100571 Dead/Cancelled |
Wireless MedCARE, LLC 2009-10-16 |