Dobbs
Dobbs Clubfoot Bar Adjustable Spring Assist w/ Markell Tarso Shoe Adapters (9 Inch thru 14 Inch)
3manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (1), Guangdong (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Dongguan Vigor Textile Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Putian Lake Sports Goods Co., Ltd. | Putian | Fujian | Manufacturer | 1 |
Record
| Listed by | D-Bar Enterprises, LLC |
|---|---|
| FDA product code | ITN |
| Device type | Splint, Denis Brown |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3675 |
| Premarket notification | Exempt |
| Record published | 2021-04-17 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SDCBMD2.0 | In distribution | |
| DCB-REG | In distribution | |
| EZCLKMD-REG | In distribution | |
| QDCB-SM | In distribution | |
| QDCB2.0 | In distribution | |
| QDCB-REG | In distribution | |
| IADCB-REG | In distribution | |
| EZCLK-SM | In distribution | |
| DCB-SM | In distribution | |
| SDCBMD-REG | In distribution | |
| SDCBMD-SM | In distribution | |
| IADCB-SM | In distribution | |
| EZCLK-REG | In distribution | |
| EZCLKMD-SM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ponseti® Plus Abduction Bar | MD Orthopaedics | 13 |
| Ponseti® Lite | MD Orthopaedics | 12 |
| MD Orthopaedics | MD Orthopaedics | 6 |
| Mitchell Ponseti® Move Bar | MD Orthopaedics | 6 |
| Mitchell Ponseti® Bracing System | MD Orthopaedics | 1 |
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.