21 CFR 890.5740 — Pad, Heating, Powered
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5740
Identification
A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IRT | Pad, Heating, Powered | 2 | 42 | |
| OZC | Over The Counter Thermal Treatment For Acne. | 2 | 1 |
Special Controls
IRT — Pad, Heating, Powered
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.
eCFR
OZC — Over The Counter Thermal Treatment For Acne.
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.
eCFR
