| Primary Device ID | 06975803350222 |
| NIH Device Record Key | 45a35484-df59-44d6-a385-edfd6f112849 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Youwen |
| Version Model Number | black waist |
| Company DUNS | 544496113 |
| Company Name | Shanghai Youwen Medical Technology Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06975803350222 [Primary] |
| ILO | Pack, Hot Or Cold, Water Circulating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-03 |
| Device Publish Date | 2025-09-25 |
| 06975803351052 | 12L cold therapy machine/system/set/unit with hip pad |
| 06975803351045 | 12L cold therapy machine/system/set/unit with shoulder pad |
| 06975803351038 | 12L cold therapy machine/system/set/unit with knee pad |
| 06975803351021 | 12L cold therapy machine/system/set/unit with universal pad |
| 06975803351014 | 5L cold therapy machine/system/set/unit with universal pad |
| 06975803350888 | 6L cold therapy machine/system/set/unit V2 |
| 06975803350871 | 6L cold therapy machine/system/set/unit V1 |
| 06975803350857 | 12L cold therapy machine/system/set/unit |
| 06975803350840 | 12L cold therapy machine/system/set/unit |
| 06975803350833 | 12L cold therapy machine/system/set/unit |
| 06975803350826 | 5L cold therapy machine/system/set/unit |
| 06975803350819 | 5L cold therapy machine/system/set/unit |
| 06975803350437 | disposable head cuff |
| 06975803350420 | disposable face cuff 3.0 |
| 06975803350413 | disposable face cuff 2.0 |
| 06975803350406 | disposable face cuff |
| 06975803350390 | Youwen cold therapy hip pad |
| 06975803350383 | Youwen cold therapy shoulder pad |
| 06975803350376 | Youwen cold therapy knee pad |
| 06975803350352 | Youwen ice blanket 2.0 |
| 06975803350345 | Youwen cold therapy knee pad 3.0 |
| 06975803350338 | Youwen cold therapy shoulder pad 3.0 |
| 06975803350321 | Youwen cold therapy face pad 3.0 |
| 06975803350314 | Youwen cold therapy face pad 2.0 |
| 06975803350307 | Youwen cold therapy face pad |
| 06975803350291 | Youwen cold therapy universal pad 2.0 |
| 06975803350284 | Youwen cold therapy universal pad |
| 06975803350277 | Youwen cold therapy ankle pad |
| 06975803350260 | Youwen cold therapy elbow pad |
| 06975803350253 | Youwen ice blanket |
| 06975803350246 | Youwen cold therapy hip pad |
| 06975803350239 | Youwen cold therapy thigh pad |
| 06975803350222 | Youwen cold therapy waist pad |
| 06975803350215 | Youwen cold therapy head pad |
| 06975803350208 | Youwen cold therapy shoulder pad |
| 06975803350192 | Youwen cold therapy knee pad |
| 06975803350185 | Youwen cold therapy hand pad |
| 06975803350178 | Youwen ice blanket 2.0 |
| 06975803350161 | Youwen cold therapy knee pad 3.0 |
| 06975803350154 | Youwen cold therapy shoulder pad 3.0 |
| 06975803350147 | Youwen cold therapy face pad 3.0 |
| 06975803350130 | Youwen cold therapy face pad 2.0 |
| 06975803350123 | Youwen cold therapy face pad |
| 06975803350116 | Youwen cold therapy universal pad 2.0 |
| 06975803350109 | Youwen cold therapy universal pad |
| 06975803350093 | Youwen cold therapy ankle pad |
| 06975803350086 | Youwen cold therapy elbow pad |
| 06975803350079 | Youwen ice blanket |
| 06975803350062 | Youwen cold therapy hip pad |
| 06975803350055 | Youwen cold therapy thigh pad |