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 |