Dobbs

Dobbs Clubfoot Bar Adjustable Spring Assist w/ Markell Tarso Shoe Adapters (9 Inch thru 14 Inch)

Registry build 21.09.26
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.

Chinese manufacturers registered for FDA product code ITN
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

Regulatory record for Dobbs
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

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 numbers for Dobbs
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer