Intermittent Compressor System
FDA 510(k) K964957 · Eischoco, Inc.
510(k) numberK964957
Submission
- Device name
- Intermittent Compressor System
- Applicant
- Eischoco, Inc.
Gresham, OR, US - Received
- December 11, 1996
- Decision date
- February 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IRP – Massager, Powered Inflatable Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5650
- Specialty
- Physical Medicine
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| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air…IRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 04/30/2026SE |
| K252386 | Hot and Cold Compression System (A02-C-032)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/03/2026SE |
| K253076 | Cryopush Cold Compression Device (A02-P-001)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/02/2026SE |
| K251622 | Hand Massager (SM004D)IRP · Traditional | Ningbo Zhenhai Yihao Electronic Technology Co.… | 01/28/2026SE |
More from Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K991921 | Intermittent Compression Boot for OTCIRP · Traditional | 08/13/1999SE |
Questions and answers
When was Intermittent Compressor System cleared by the FDA?
Intermittent Compressor System (K964957) received a 510(k) decision of Substantially Equivalent on February 24, 1997, 75 days after the submission was received.
What is the product code of K964957?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.