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 |