21 CFR 890.5710 — Pack, Hot Or Cold, Disposable
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5710
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | 1 | 82 | |
| MPO | Infant Heel Warmer (Chemical Heat Pack) | 1 | 11 | 3rd Party |
| OMW | Adhesive Backed Thermal Skin Patches | 1 | 0 |
