Hot/Ice System Sterile Conformable/Disp. Blankets
FDA 510(k) K931843 · Hollister, Inc.
510(k) numberK931843
Submission
- Device name
- Hot/Ice System Sterile Conformable/Disp. Blankets
- Applicant
- Hollister, Inc.
Libertyville, IL, US - Received
- April 13, 1993
- Decision date
- February 2, 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
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| 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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Questions and answers
When was Hot/Ice System Sterile Conformable/Disp. Blankets cleared by the FDA?
Hot/Ice System Sterile Conformable/Disp. Blankets (K931843) received a 510(k) decision of Substantially Equivalent on February 2, 1994, 295 days after the submission was received.
What is the product code of K931843?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.