Hot and Cold Compression System A02-C-032
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252386 FDA 510(k)
- FDA Product Code
- IRP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5650 FDA 510(k)
- Regulation Number
- 890.5650 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hot and Cold Compression System A02-C-032 is a powered inflatable tube massager. It is designed to provide therapeutic compression along with hot and cold temperature regulation.
This device is regulated under the Physical Medicine specialty and has received FDA 510(k) clearance. It is identified by the product code IRP and regulation number 890.5650.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hot and Cold Compression System (A02-C-032) (K252386) — FDA 510(k ..., K252386 - Hot and Cold Compression System (A02-C-032), Hot and Cold Compression System (A02-C-032) 510(k)… - FDA.report, Hot and Cold Therapy Machine - OEM - CryoPush
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252386 | Class II | Active |
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Manufacturer
- Manufacturer
- Chengdu Cryo-push Medical Technology Co., Ltd.
- FDA Applicant
- Chengdu Cryo-Push Medical Technology Co.,Ltd
Sources (1)
- FDA 510(k) K252386 24 fields · synced Sep 25, 2026