The following data is part of a premarket notification filed by Aquasoothe with the FDA for Auqasoothe/aqua Med.
| Device ID | K915729 |
| 510k Number | K915729 |
| Device Name: | AUQASOOTHE/AQUA MED |
| Classification | Massager, Therapeutic, Electric |
| Applicant | AQUASOOTHE 2808 CONCORD LAKE RD. Kannapolis, NC 28083 |
| Contact | Dave B Marlin |
| Correspondent | Dave B Marlin AQUASOOTHE 2808 CONCORD LAKE RD. Kannapolis, NC 28083 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-04-29 |