DWJ

System, Thermal Regulating

Product code

DWJ

Device name

System, Thermal Regulating

Device class

Class 2

21 CFR

21 CFR 870.5900

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

14

Summaries archived here

13 (direct download)

510(k) clearances (all years, FDA)

161 (all years; only the last 3 years are listed here)

FDA classification definition

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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (14)

Last three years. Most recent: 2026-08-21.

13 summaries are archived here for direct download.