Well Brain International, Ltd.
Brand owner, China. 3 products catalogued, 4 clearances.
Well Brain International, Ltd. holds an FDA establishment registration in China. Its registration names no device type; it is in this index because it catalogues devices under its own name. 3 of its products are catalogued under its own name.
3products catalogued under its own name
4510(k) clearances
Registration
| Registered name | Well Brain International , Ltd. |
|---|---|
| Status | Not current |
| DUNS | 663213551 |
Location
| Country | China |
|---|
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Gymform Total ABS | NGX | 1 |
| Gymform Total ABS Platinum | NGX | 1 |
| Gymform Abs-A-Round | NGX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K202653 | 2021-01-15 | NGX | Traditional | This company |
| K142055 | 2015-05-11 | NGX | Traditional | This company |
| K130074 | 2013-08-15 | NGX | Traditional | This company |
| K111781 | 2012-07-11 | NGX | Traditional | This company |
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.