Yiwu Inwell Craft&Gift Co., Ltd.
Registered establishment in Jin Hua, Zhejiang, China. 7 device types.
Yiwu Inwell Craft&Gift Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Laser, Comb, Hair, Orthosis, Limb Brace and 5 other device types. Its earliest product listing with the FDA dates from 2026.
Registration
| Registered name | YIWU INWELL CRAFT&GIFT CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3031980484 |
| FEI number | 3031980484 |
| Establishment type | Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter |
Location
| City | Jin Hua |
|---|---|
| Province | Zhejiang |
| Address | No118.Yongjun Road,North Beiyuan District, Yiwu |
| Postal code | 322000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Joint, Knee, External Brace | Class 1 | 2026 | 137 | |
| Lamp, Infrared, Therapeutic Heating | Class 2 | 6-in-1 Rechargeable Scalp Massager Brush | 2026 | 235 |
| Laser, Comb, Hair | Class 2 | 6-in-1 Rechargeable Scalp Massager Brush | 2026 | 30 |
| Massager, Therapeutic, Electric | Class 1 | 6-in-1 Rechargeable Scalp Massager Brush | 2026 | 437 |
| Orthosis, Limb Brace | Class 1 | Complete Joint Support Kit (Knee Brace with Dial Adjustment One Size Wrist Wrap) | 2026 | 144 |
| Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | Class 2 | OCD MT Cap, Treatment Pack | 2026 | 3 |
| Transcranial Magnetic Stimulator | Class 2 | Treatment Pack, MT Cap, OCD MT Cap | 2026 | 3 |
Clearances
No clearance names Yiwu Inwell Craft&Gift Co., Ltd. as applicant. 5 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K231350 | 2023-06-08 | QCI | Special | Neuronetics Inc. |
| K212289 | 2022-05-06 | QCI | Traditional | Neuronetics Inc. |
| K213543 | 2021-12-10 | OBP | Special | Neuronetics Inc. |
| K190685 | 2019-07-26 | OAP | Traditional | Xuzhou Kernel Medical Equipment Co Ltd |
| K161519 | 2016-09-11 | OBP | Traditional | Neuronetics Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.