TC-1000, TC-1050 Thermal Regulating System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Tc-1000, Tc-1050 System

510(k) Number

K914805 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Gaymar Industries, Inc. →

• What clinical scenarios is the TC-1000, TC-1050 Thermal Regulating System primarily used for?

  The TC-1000 and TC-1050 systems are designed for controlled thermal management in cardiovascular applications, particularly during surgical procedures or patient stabilization where precise temperature regulation is critical. This includes scenarios like hypothermia induction or maintenance, or hyperthermia therapy in cardiac surgeries or critical care settings.

• Is the TC-1000, TC-1050 System single-use or reusable, and what does that mean for maintenance?

  The TC-1000, TC-1050 System is explicitly described as a reusable device. This means it is intended for repeated use across multiple patients, provided it is properly cleaned, disinfected, and maintained according to manufacturer guidelines to ensure safety and performance. Reusability reduces waste but requires adherence to strict infection control protocols.

• How is the TC-1000, TC-1050 System regulated, and what does that imply for purchasing or clinical use?

  The system holds FDA 510(k) clearance (K914805) under product code DWJ, indicating it has been deemed substantially equivalent to a legally marketed predicate device. This clearance is specific to thermal regulating systems and does not imply any clinical indication—it only confirms regulatory compliance for marketing and use in the U.S. Clinicians should verify compatibility with their facility’s protocols and ensure proper training for operation.

• Are there any special storage requirements for the TC-1000, TC-1050 System, particularly regarding temperature or handling?

  The provided data does not specify any special storage conditions (e.g., temperature ranges, humidity, or environmental controls) for the TC-1000/TC-1050 System. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve functionality and prevent contamination. Always follow the manufacturer’s instructions for storage and maintenance.

• What distinguishes the TC-1000 from the TC-1050 in terms of functionality or intended use?

  The data does not provide explicit technical distinctions between the TC-1000 and TC-1050 models beyond both being part of the same thermal regulating system family. The differences, if any, likely relate to specifications like temperature range, power output, or design features (e.g., cooling vs. heating capacity), which would be detailed in the manufacturer’s technical documentation or user manual. Clinicians should consult Gaymar Industries for model-specific details.