TS1000 Portable Disposable Cold Therapy System
FDA 510(k) K940160 · Burke Neutech, Inc.
510(k) numberK940160
Submission
- Device name
- TS1000 Portable Disposable Cold Therapy System
- Applicant
- Burke Neutech, Inc.
Largo, FL, US - Received
- January 12, 1994
- Decision date
- May 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| K213097 | Armory MotionILO · Traditional | Pain Management Technologies, Inc. | 06/10/2022SE |
| K083008 | CoolskinILO · Abbreviated | Elbio Co., Ltd. | 06/10/2009SE |
| K073675 | T-Pump Localized Temperature Therapy PumpILO · Traditional | Gaymar Industries, Inc. | 05/08/2008SE |
| 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 |
More from Ormed GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K955326 | Sports Contrast Therapy System ST 7000ILO · Traditional | 04/10/1996SN |
| K952117 | EpilatorKCX · Traditional | 10/19/1995SE |
| K943497 | Contrast 7000 Therapy SystemILO · Traditional | 06/07/1995SE |
| K945803 | Thermaflex, Model SD 55 C.P.M.H.JFA · Traditional | 05/11/1995SE |
| K942926 | Neuro-AideGWY · Traditional | 08/03/1994SE |
| K926151 | LSI6000 Thermal Therapy SystemILO · Traditional | 05/26/1993SE |
Questions and answers
When was TS1000 Portable Disposable Cold Therapy System cleared by the FDA?
TS1000 Portable Disposable Cold Therapy System (K940160) received a 510(k) decision of Substantially Equivalent on May 27, 1994, 135 days after the submission was received.
What is the product code of K940160?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.