The following data is part of a premarket notification filed by Franks Electronics with the FDA for Neuroflax, Epk.
Device ID | K831990 |
510k Number | K831990 |
Device Name: | NEUROFLAX, EPK |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | FRANKS ELECTRONICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-21 |
Decision Date | 1983-11-28 |