The following data is part of a premarket notification filed by Ultramind International Ltd. with the FDA for Relaxplus.
| Device ID | K951213 |
| 510k Number | K951213 |
| Device Name: | RELAXPLUS |
| Classification | Device, Biofeedback |
| Applicant | ULTRAMIND INTERNATIONAL LTD. P.O. BOX 1309 88112 Eilat, IL 88112 |
| Contact | Emanuel A Rosen |
| Correspondent | Emanuel A Rosen ULTRAMIND INTERNATIONAL LTD. P.O. BOX 1309 88112 Eilat, IL 88112 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-17 |
| Decision Date | 1995-09-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RELAXPLUS 77827111 3816968 Live/Registered |
Tropitone Furniture Co., Inc. 2009-09-15 |