FDA device listing
Ice Bucket; Cold Therapy System,Sleeve, Limb, Compressible Garment
FDA device listing 1939106207 · HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD
Key facts
| Proprietary names | Ice Bucket; Cold Therapy System,Sleeve, Limb, Compressible Garment |
|---|---|
| Owner/operator | HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD |
| Owner/operator number | 10058861 |
| Premarket submissions | K110276 |
| Product codes | IRP, JOW |
| Device names | IRP - Massager, Powered Inflatable Tube, JOW - Sleeve, Limb, Compressible |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.5800, 890.5650 |
| Review panels | Cardiovascular, Physical Medicine |
| Registered establishments | HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD |
| Establishment registrations | 3014542717 |
| FEI numbers | 3014542717 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database