The following data is part of a premarket notification filed by Healthmate International, Llc with the FDA for Healthmateforever.
| Device ID | K121757 |
| 510k Number | K121757 |
| Device Name: | HEALTHMATEFOREVER |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | HEALTHMATE INTERNATIONAL, LLC 709 E. 97TH STREET Kansas City, MO 64131 |
| Contact | Mei Dodson |
| Correspondent | Mei Dodson HEALTHMATE INTERNATIONAL, LLC 709 E. 97TH STREET Kansas City, MO 64131 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2012-11-20 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEALTHMATEFOREVER 85050385 4035888 Live/Registered |
Healthmate International, LLC 2010-05-28 |