Procare
Binder, ABD 4PNL 12 IN 62 IN - 74 IN Unsx
20manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (4), Shanghai (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Yishun Medical Equipment Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 10 |
| Shenzhen Caremed Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Guangzhou Yifangjia Textile And Garment Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 5 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Picard Healthcare Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
| Dongguan NAN YOU Sporting Goods Enterprise Ltd | Dongguan | Guangdong | Contract manufacturer | 23 |
| Hengshui Xukang Medical Appliances Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 21 |
| Dongguan Park Sport Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 20 |
| Taicang Yigao Medical Technology Co., Ltd. | Taicang | Jiangsu | Manufacturer | 20 |
Showing 12 of 20. All 20 manufacturers in China registered for Binder, Abdominal
Record
| Listed by | DJO, LLC, United States |
|---|---|
| FDA product code | FSD |
| Device type | Binder, Abdominal |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5160 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-21 |
| Record revised | 2023-09-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 79-92290 | In distribution | |
| 155-79-89210 | In distribution | |
| 155-79-89220 | In distribution | |
| 155-79-89090 | In distribution | |
| 155-79-89071 | In distribution | |
| 155-79-89091 | In distribution | |
| 155-79-89070 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 106 |
| Binder, Abdominal | Tetra Medical Supply Corp. | 55 |
| Kendall | Cardinal Health | 28 |
| Momcozy | Shenzhen Root Innovation Technology Co., Ltd. | 24 |
| Dale Abdominal Binder | Dale Medical Products, Inc. | 18 |
| E.M Adams Co., Inc. | E.M. Adams Co., Inc. | 16 |
| Abdominal Binder | Dynarex Corp. | 10 |
| Ab Binder | Pepper Medical, Inc. | 7 |
| M-Brace Air | Indaco SRL | 6 |
| Primo | ASP Global, LLC | 6 |
| Momcozy | Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. | 6 |
| ASP Medical | ASP Global, LLC | 6 |
Showing 12 of 121. All products under Binder, Abdominal
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.