The following data is part of a premarket notification filed by Hollywog, Llc with the FDA for The Pain Pilot (a.k.a Pain Pilot).
Device ID | K120500 |
510k Number | K120500 |
Device Name: | THE PAIN PILOT (A.K.A PAIN PILOT) |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | HOLLYWOG, LLC 2830 AMNICOLA HWY Chattanooga, TN 37406 |
Contact | Michael W Treas |
Correspondent | Michael W Treas HOLLYWOG, LLC 2830 AMNICOLA HWY 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 | 2012-02-21 |
Decision Date | 2012-08-20 |
Summary: | summary |