21 CFR 890.5110 — Bath, Paraffin
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5110
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IMC | Bath, Paraffin | 2 | 12 |
Special Controls
IMC — Bath, Paraffin
*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.
eCFR
