Artrotherm Cryotherapy and Thernotherapy
FDA 510(k) K964799 · Ormed GmbH
510(k) numberK964799
Submission
- Device name
- Artrotherm Cryotherapy and Thernotherapy
- Applicant
- Ormed GmbH
Concord, CA, US - Received
- November 29, 1996
- Decision date
- August 29, 1997
- 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
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| 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 |
| 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 |
|---|---|---|
| K964354 | Artocool-S Water Circulating Cold PackILO · Traditional | 08/29/1997SE |
Questions and answers
When was Artrotherm Cryotherapy and Thernotherapy cleared by the FDA?
Artrotherm Cryotherapy and Thernotherapy (K964799) received a 510(k) decision of Substantially Equivalent on August 29, 1997, 273 days after the submission was received.
What is the product code of K964799?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.