The following data is part of a premarket notification filed by Hollywog, Llc with the FDA for Witouch Pro.
Device ID | K120398 |
510k Number | K120398 |
Device Name: | WITOUCH PRO |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | HOLLYWOG, LLC 2830 AMMICOLA HIGHWAY Chattanooga, TN 37406 |
Contact | Michael W Treas |
Correspondent | Michael W Treas HOLLYWOG, LLC 2830 AMMICOLA HIGHWAY Chattanooga, TN 37406 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-08 |
Decision Date | 2012-08-16 |
Summary: | summary |