Electronic Code of Federal Regulations
We invite you to try out our new beta eCFR site at
https://ecfr.federalregister.gov. We have made big
changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom
right of each page!
|
e-CFR data is current as of January 14, 2021 |
Title 21 → Chapter I → Subchapter H → Part 890 → Subpart F → §890.5710 |
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart F—Physical Medicine Therapeutic Devices
§890.5710 Hot or cold disposable pack.
(a) 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.
(b) Classification. 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.
[48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]