PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
Device Facts
| Record ID | K001860 |
|---|---|
| Device Name | PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA |
| Applicant | Homedics, Inc. |
| Product Code | IMC · Physical Medicine |
| Decision Date | Aug 10, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5110 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) and maintained at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
