T-Pump Localized Temperature Therapy Pump
FDA 510(k) K073675 · Gaymar Industries, Inc.
510(k) numberK073675
Submission
- Device name
- T-Pump Localized Temperature Therapy Pump
- Applicant
- Gaymar Industries, Inc.
Buffalo, NY, US - Received
- December 28, 2007
- Decision date
- May 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5720
- Specialty
- Physical Medicine
Other 510(k)s with product code ILO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213097 | Armory MotionILO · Traditional | Pain Management Technologies, Inc. | 06/10/2022SE |
| K083008 | CoolskinILO · Abbreviated | Elbio Co., Ltd. | 06/10/2009SE |
| K072152 | Juniper CLN1 Dermal Cooling DeviceILO · Traditional | Juniper Medical, Inc. | 09/07/2007SE |
| K070402 | Modification to Polar Care 500ILO · Special | Breg, Inc. | 03/29/2007SE |
| K040317 | Ivc SystemILO · Traditional | Mark H. Friedman | 05/07/2004SE |
| K973023 | Incare Hot/Ice System Foot/Ankle BlanketILO · Traditional | Hollister, Inc. | 11/03/1997SE |
| K970197 | HTP-1500 Localized Heat Therapy PumpILO · Traditional | Adroit Medical Systems, Inc. | 09/10/1997SE |
| K964799 | Artrotherm Cryotherapy and ThernotherapyILO · Traditional | Ormed GmbH | 08/29/1997SE |
| K964354 | Artocool-S Water Circulating Cold PackILO · Traditional | Ormed GmbH | 08/29/1997SE |
| K964710 | Bledsoe Cold ControlILO · Traditional | Med Technology, Inc. | 05/09/1997SE |
More from Med Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900DWJ · Traditional | 01/20/2011SE |
| 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 |
| K930345 | TC2000 Power Unit and AccessoriesDWJ · Traditional | 08/06/1993SE |
| 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 T-Pump Localized Temperature Therapy Pump cleared by the FDA?
T-Pump Localized Temperature Therapy Pump (K073675) received a 510(k) decision of Substantially Equivalent on May 8, 2008, 132 days after the submission was received.
What is the product code of K073675?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.