The following data is part of a premarket notification filed by Headwaters, Inc. with the FDA for Cordless Massager With Heat ( Various Brand Names).
| Device ID | K945603 |
| 510k Number | K945603 |
| Device Name: | CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) |
| Classification | Vibrator, Therapeutic |
| Applicant | HEADWATERS, INC. 10 ROGERS ST., SUITE 214 Cambridge, MA 02142 |
| Contact | Rudy A Vandenbelt |
| Correspondent | Rudy A Vandenbelt HEADWATERS, INC. 10 ROGERS ST., SUITE 214 Cambridge, MA 02142 |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-15 |
| Decision Date | 1995-02-09 |