The following data is part of a premarket notification filed by Phoenix Intl. Marketing, Inc. with the FDA for Soft & Stroke.
| Device ID | K811782 |
| 510k Number | K811782 |
| Device Name: | SOFT & STROKE |
| Classification | Massager, Therapeutic, Electric |
| Applicant | PHOENIX INTL. MARKETING, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-23 |
| Decision Date | 1981-07-31 |