The following data is part of a premarket notification filed by Hollywog Llc with the FDA for Witouch Pro, Witouch, Neubac.
Device ID | K171599 |
510k Number | K171599 |
Device Name: | WiTouch Pro, WiTouch, Neubac |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | Hollywog LLC 2830 Amnicola Highway Chattanooga, TN 37406 |
Contact | Michael Treas |
Correspondent | Michael Treas Hollywog LLC 2830 Amnicola Highway Chattanooga, TN 37406 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-01 |
Decision Date | 2017-09-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00853096004021 | K171599 | 000 |