The following data is part of a premarket notification filed by Srs Medical Systems, Inc. with the FDA for Regain Desktop.
| Device ID | K003127 |
| 510k Number | K003127 |
| Device Name: | REGAIN DESKTOP |
| Classification | Device, Biofeedback |
| Applicant | SRS MEDICAL SYSTEMS, INC. 14950 N.E. 95TH ST. Redmond, WA 98052 |
| Contact | Lee Brody |
| Correspondent | Lee Brody SRS MEDICAL SYSTEMS, INC. 14950 N.E. 95TH ST. Redmond, WA 98052 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-06 |
| Decision Date | 2001-01-04 |