Device type

System, Thermal Regulating

Product code DWJ · Class II · 21 CFR 870.5900 · Cardiovascular

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

FDA classification database