The following data is part of a premarket notification filed by Neuroscience Therapy Corp. with the FDA for P-stim System.
| Device ID | K050123 |
| 510k Number | K050123 |
| Device Name: | P-STIM SYSTEM |
| Classification | Stimulator, Electro-acupuncture |
| Applicant | NEUROSCIENCE THERAPY CORP. 135 LAKE STREET SOUTH SUITE 100 Kirkland, WA 98033 |
| Contact | Jan Mccomb |
| Correspondent | Jan Mccomb NEUROSCIENCE THERAPY CORP. 135 LAKE STREET SOUTH SUITE 100 Kirkland, WA 98033 |
| Product Code | BWK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-19 |
| Decision Date | 2006-03-30 |
| Summary: | summary |