Unit, Chilling

FDA product code IMF · Class I (low risk) · 21 CFR 890.5940 · Physical Medicine

2510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K900419CRYOTRON-UL30IMF · Traditional Henley Intl.02/27/1990SE
K871112Peltiertherapy(C) Heat/Cold TreatmentIMF · Traditional Henley Intl.05/06/1987SE

Recalls

RecallProductFirmInitiated
Z-2590-2020 Class IIThis is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic…The device accessories were not labeled with appropriate latex warning. Djo, LLC06/25/2018Terminated