Thera-Pak
FDA 510(k) K780452 · Hydro-Med Products, Inc.
510(k) numberK780452
Submission
- Device name
- Thera-Pak
- Applicant
- Hydro-Med Products, Inc.
Walker, MI, US - Received
- March 21, 1978
- Decision date
- June 21, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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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 |
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| K940152 | Camera Cover with Tear TipFEM · Traditional | 10/28/1994SE |
| K934630 | Universal Video/Laser Arm DrapeKKX · Traditional | 10/28/1994SE |
| K923099 | X-Ray DrapesIWQ · Traditional | 10/15/1992SE |
| K863872 | Tamper HamperLPZ · Traditional | 02/10/1987SE |
| K853281 | Easytop · Traditional | 08/21/1985SE |
| K842304 | The Pathfinder · Traditional | 08/01/1984SE |
| K834407 | Sterile Disposable Spinal NeedlesFMI · Traditional | 03/19/1984SE |
| K812405 | Sterile TV Camera & Cord CoverKQM · Traditional | 10/20/1981SE |
Questions and answers
When was Thera-Pak cleared by the FDA?
Thera-Pak (K780452) received a 510(k) decision of Substantially Equivalent on June 21, 1978, 92 days after the submission was received.
What is the product code of K780452?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.