IMF — Unit, Chilling Class I

FDA Device Classification

FDA product code IMF covers "Unit, Chilling", a Class I medical device regulated under 21 CFR 890.5940. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IMF
Device Class
Class I
Regulation Number
890.5940
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K900419henley intlCRYOTRON-UL30February 27, 1990
K871112henley intlPELTIERTHERAPY(C) HEAT/COLD TREATMENTMay 6, 1987