TC2000 Power Unit and Accessories
FDA 510(k) K930345 · Gaymar Industries, Inc.
510(k) numberK930345
Submission
- Device name
- TC2000 Power Unit and Accessories
- Applicant
- Gaymar Industries, Inc.
Orchard Park, NY, US - Received
- January 25, 1993
- Decision date
- August 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DWJ – System, Thermal Regulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- 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).
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| K262089 | Disposable Warming BlanketDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 08/21/2026SE |
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| K260278 | ThermAffyx(TM) Patient Safety SystemDWJ · Traditional | Stihler Electronic GmbH | 07/08/2026SE |
| K260903 | Hot Pink Pad Warming SystemDWJ · Traditional | Xodus Medical, Inc. | 04/16/2026SE |
| K252861 | Warming SystemDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 04/07/2026SE |
| K251974 | Arctic Sun Temperature Management System (Model 5000)DWJ · Traditional | Medivance, Inc. | 10/24/2025SE |
| K242964 | Celsi WarmerDWJ · Traditional | Hadleigh Health Technologies | 06/20/2025SE |
| K243942 | Arctic Sun Stat Temperature Management SystemDWJ · Traditional | Medivance, Inc. | 04/30/2025SE |
| K232627 | HotDog Warming Mattress + Return ElectrodeDWJ · Special | Augustine Temperature Management, LLC | 04/18/2024SE |
| K232502 | Cocoon Convective Warming System, Model CWS7000DWJ · Traditional | Care Essentials Pty, Ltd. | 02/21/2024SE |
More from Care Essentials Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900DWJ · Traditional | 01/20/2011SE |
| K073675 | T-Pump Localized Temperature Therapy PumpILO · Traditional | 05/08/2008SE |
| K962788 | Clinidyne Rotational Therapy Mattress SystemIKZ · Traditional | 04/30/1997SE |
| K963067 | Sof. Press Epc 51 SystemJOW · Traditional | 01/28/1997SE |
| K961854 | SPR Plus II Overlay System (CL250/CL212FNM · Traditional | 08/09/1996SE |
| K942881 | TC 3000DWJ · Traditional | 05/23/1995SE |
| K914921 | SCM-3 and AccessoriesIKY · Traditional | 03/12/1992SE |
| K914805 | TC-1000, TC-1050 SystemDWJ · Traditional | 01/07/1992SE |
| K914851 | CLA-1400 SystemIOQ · Traditional | 11/13/1991SE |
| K912051 | Medi-Therm (MTA-5900) & Detachable HosesDWJ · Traditional | 07/30/1991SE |
Questions and answers
When was TC2000 Power Unit and Accessories cleared by the FDA?
TC2000 Power Unit and Accessories (K930345) received a 510(k) decision of Substantially Equivalent on August 6, 1993, 193 days after the submission was received.
What is the product code of K930345?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.