The following data is part of a premarket notification filed by Neurofitness with the FDA for Nf-1 Mindpeace.
Device ID | K895175 |
510k Number | K895175 |
Device Name: | NF-1 MINDPEACE |
Classification | Cranial Electrotherapy Stimulator To Treat Depression |
Applicant | NEUROFITNESS 14770 N.E. 95TH ST. Redmond, WA 98052 |
Contact | Carl Christine |
Correspondent | Carl Christine NEUROFITNESS 14770 N.E. 95TH ST. Redmond, WA 98052 |
Product Code | JXK |
CFR Regulation Number | 882.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-10 |
Decision Date | 1989-11-08 |