Autochill Accessory Kit
FDA 510(k) K925677 · Aircast, Inc.
510(k) numberK925677
Submission
- Device name
- Autochill Accessory Kit
- Applicant
- Aircast, Inc.
Summit, NJ, US - Received
- July 16, 1992
- Decision date
- April 14, 1993
- 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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| 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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| K992454 | Venaflow System, Model 30AJOW · Traditional | 01/13/2000SE |
| K964238 | Aircast Vena Flow Sterile Disposable CuffsJOW · Traditional | 09/08/1997SE |
| K961676 | Aircast Venaflow System (Modification)JOW · Traditional | 03/28/1997SE |
| K933977 | Aircast Edemaflow SystemJOW · Traditional | 12/07/1993SE |
| K932900 | Aircast Venaflow SystemJOW · Traditional | 10/25/1993SE |
| K812094 | Aircast Pneumatic Knee BraceITQ · Traditional | 08/13/1981SE |
| K810288 | Aircast Tennis Arm BandIQI · Traditional | 02/12/1981SE |
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Questions and answers
When was Autochill Accessory Kit cleared by the FDA?
Autochill Accessory Kit (K925677) received a 510(k) decision of Substantially Equivalent on April 14, 1993, 272 days after the submission was received.
What is the product code of K925677?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.