Health Design Polycast Cast Boot
6 catalogue numbers from HD-CB-PC5, listed by Darco International, Inc., United States, under Shoe, Cast. 20 manufacturers in China are registered for this product code.
20manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (4), Zhejiang (4). 7 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 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Shenzhen Zhouyang Medical Care Product Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Hubei Dacheng Medical Technology Co., Ltd. | Xianning | Hubei | Contract manufacturer | 12 |
| Fengtai County Guqiao Town Changxing Shoe Factory | Huainan | Anhui | Contract manufacturer | 6 |
| Ocean Well Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
| Wenzhou First Light Industry Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 3 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Suzhou Pipi Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
Showing 12 of 20. All 20 manufacturers in China registered for Shoe, Cast
Record
| Listed by | Darco International, Inc., United States |
|---|---|
| FDA product code | IPG |
| Device type | Shoe, Cast |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 12, case of 36 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HD-CB-PC5 | In distribution | |
| HD-CB-PC4 | In distribution | |
| HD-CB-PC3 | In distribution | |
| HD-CB-PC1 | In distribution | |
| HD-CB-PC2 | In distribution | |
| HD-CB-PC6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 233 |
| Vive | Vive Health LLC | 46 |
| Elite Orthopaedics | Elite Orthopaedics, Inc. | 14 |
| Tairuibosi | Tianjin Tairuibosi Medical Appliance Co., Ltd. | 12 |
| Shoe, Cast | Tetra Medical Supply Corp. | 12 |
| Darco® SlimLine™ cast boot | Darco International, Inc. | 8 |
| Gaitkeeper® Cast Shoe | Position Health, LLC | 8 |
| Cast boot, canvas | Darco International, Inc. | 6 |
| Health Design Low Profile Cast Boot | Darco International, Inc. | 6 |
| Rhino | MD Orthopaedics | 6 |
| Darco® Body Armor® Cast Shoe | Darco International, Inc. | 6 |
| Darco® SlimLine™ Pediatric | Darco International, Inc. | 6 |
Showing 12 of 45. All products under Shoe, Cast
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.