The following data is part of a premarket notification filed by Homedics, Inc. with the FDA for Paraspa Paraffin Bath, Paraspap Mini, Paraspa Ultra.
| Device ID | K001860 |
| 510k Number | K001860 |
| Device Name: | PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA |
| Classification | Bath, Paraffin |
| Applicant | HOMEDICS, INC. 3000 PONTIAC TRAIL Commerce Township, MI 48390 |
| Contact | Micheal Nelson |
| Correspondent | Micheal Nelson HOMEDICS, INC. 3000 PONTIAC TRAIL Commerce Township, MI 48390 |
| Product Code | IMC |
| CFR Regulation Number | 890.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-19 |
| Decision Date | 2000-08-10 |