OMW · Adhesive Backed Thermal Skin Patches
Physical Medicine · 21 CFR 890.5710 · Class 1
Overview
| Product Code | OMW |
|---|---|
| Device Name | Adhesive Backed Thermal Skin Patches |
| Regulation | 21 CFR 890.5710 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
Classification Rationale
Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
