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FDA PRODUCT CODE · CLASS II

DWJ — System, Thermal Regulating

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).

DEVICE CLASS
Class II
REGULATION
21 CFR 870.5900
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K260278Stihler Electronic GmbH · 510k2026-07-08
K260903Xodus Medical, Inc. · 510k2026-04-16
K252861Hangzhou Tappa Medical Technology Co., Ltd. · 510k2026-04-07
K251974Medivance, Inc. · 510k2025-10-24
K242964Hadleigh Health Technologies · 510k2025-06-20
K243942Medivance, Inc. · 510k2025-04-30

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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