DeRoyal
Cast Boot, Slimline Darco®Blue, Ped L
20manufacturers in China registered for this device type
233catalogue 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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | IPG |
| Device type | Shoe, Cast |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12, case of 6, case of 4, case of 36 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2037-03 | In distribution | |
| 2039-02 | In distribution | |
| 503F20 | In distribution | |
| A152406 | In distribution | |
| 2042-03 | In distribution | |
| 2045-05 | In distribution | |
| 2041-08 | In distribution | |
| 2027-05 | In distribution | |
| 2039-03 | In distribution | |
| DS1016-12 | In distribution | |
| 2041-09 | In distribution | |
| 6-614A-01 | In distribution | |
| 2037-02 | In distribution | |
| 6-604A-02 | In distribution | |
| 6-602A-04 | In distribution | |
| 6-610A-02 | In distribution | |
| 2038-05 | In distribution | |
| 6-603A-04 | In distribution | |
| 2007-06 | In distribution | |
| 2020-13 | In distribution | |
| 603F10 | In distribution | |
| 6-603A-02-POC | In distribution | |
| 6-614A-00 | In distribution | |
| 2005-01 | In distribution | |
| 2020-14 | In distribution | |
| 2041-02 | In distribution | |
| 506F10 | In distribution | |
| DS1014-14 | In distribution | |
| 6-602A-98 | In distribution | |
| 2042-07 | In distribution | |
| 6-611A-03 | In distribution | |
| 6-607A-98 | In distribution | |
| 6-611A-04 | In distribution | |
| 2042-09 | In distribution | |
| 6-613A-04 | In distribution | |
| 2006-02 | In distribution | |
| 6-608A-03 | In distribution | |
| A152307 | In distribution | |
| DS1014-16 | In distribution | |
| 2038-01 | In distribution | |
| 2007-07 | In distribution | |
| A152308 | In distribution | |
| 2044-04 | In distribution | |
| 2033-03 | In distribution | |
| 2006-10 | In distribution | |
| 2039-05 | In distribution | |
| HS1005-16 | In distribution | |
| HS1003-12 | In distribution | |
| 6-608A-04 | In distribution | |
| 6-615A-01 | In distribution | |
| 6-600A-04 | In distribution | |
| HS1005-14 | In distribution | |
| 1178MSPP | In distribution | |
| 2001-04 | In distribution | |
| 2005-05 | In distribution | |
| 698F10 | In distribution | |
| 2041-07 | In distribution | |
| 1178MMPP | In distribution | |
| 598F10 | In distribution | |
| 6-602A-03 | In distribution | |
| 6-607A-03 | In distribution | |
| 2020-03 | In distribution | |
| 1178MXLPP | In distribution | |
| 504F20 | In distribution | |
| 605F10 | In distribution | |
| 2001-01 | In distribution | |
| 6-603A-02 | In distribution | |
| DS1015-12 | In distribution | |
| 6-600A-03 | In distribution | |
| 6-614A-02 | In distribution | |
| 6-615A-02 | In distribution | |
| 2004-01 | In distribution | |
| 2044-03 | In distribution | |
| 2021-04 | In distribution | |
| 2035-05 | In distribution | |
| 2006-06 | In distribution | |
| 2037-05 | In distribution | |
| 6-614A-03 | In distribution | |
| A152405 | In distribution | |
| 6-607A-05 | In distribution | |
| 6-614A-04 | In distribution | |
| 2021-12 | In distribution | |
| 2035-03 | In distribution | |
| 2006-04 | In distribution | |
| 6-601A-02 | In distribution | |
| 6-612A-03 | In distribution | |
| 2007-02 | In distribution | |
| 6-604A-05 | In distribution | |
| 2006-08 | In distribution | |
| 2038-03 | In distribution | |
| 6-614A-05 | In distribution | |
| 2006-09 | In distribution | |
| 2039-00 | In distribution | |
| 6-604A-04 | In distribution | |
| 2007-05 | In distribution | |
| DS1015-14 | In distribution | |
| DS1013-14 | In distribution | |
| 2044-08 | In distribution | |
| 6-602A-02 | In distribution | |
| 1178FMPP | In distribution | |
| DS1014-10 | In distribution | |
| 2020-12 | In distribution | |
| 2005-04 | In distribution | |
| 2041-00 | In distribution | |
| 2035-01 | In distribution | |
| DS1015-10 | In distribution | |
| 2001-03 | In distribution | |
| 6-615A-03 | In distribution | |
| A152305 | In distribution | |
| 1178FLPP | In distribution | |
| 2032-02 | In distribution | |
| 6-604A-03 | In distribution | |
| 2006-03 | In distribution | |
| 505F20 | In distribution | |
| 2021-14 | In distribution | |
| 2007-10 | In distribution | |
| DS1013-10 | In distribution | |
| 2027-01 | In distribution | |
| 503F10 | In distribution | |
| 6-604A-03-POC | In distribution | |
| A150008 | In distribution | |
| 6-604A-02-POC | In distribution | |
| 505F10 | In distribution | |
| 2021-01 | In distribution | |
| 2006-01 | In distribution | |
| 2004-05 | In distribution | |
| 2006-05 | In distribution | |
| 6-600A-02 | In distribution | |
| 6-602A-01 | In distribution | |
| A150006 | In distribution | |
| 2038-04 | In distribution | |
| 6-613A-02 | In distribution | |
| 2044-09 | In distribution | |
| HS1005-08 | In distribution | |
| 2037-01 | In distribution | |
| 2027-04 | In distribution | |
| 2007-08 | In distribution | |
| 2021-03 | In distribution | |
| 6-615A-04 | In distribution | |
| HS1005-12 | In distribution | |
| 2045-02 | In distribution | |
| DS1013-12 | In distribution | |
| 2006-07 | In distribution | |
| 6-610A-04 | In distribution | |
| 6-612A-05 | In distribution | |
| 2021-11 | In distribution | |
| 2037-04 | In distribution | |
| 2039-01 | In distribution | |
| 2020-02 | In distribution | |
| DS1012-00 | In distribution | |
| 6-614A-99 | In distribution | |
| 2039-98 | In distribution | |
| A152407 | In distribution | |
| 2033-01 | In distribution | |
| 2007-03 | In distribution | |
| 6-600A-98 | In distribution | |
| 6-601A-04 | In distribution | |
| 2004-02 | In distribution | |
| 2044-01 | In distribution | |
| DS1014-12 | In distribution | |
| 6-608A-05 | In distribution | |
| 6-604A-04-POC | In distribution | |
| 2045-04 | In distribution | |
| 6-607A-04 | In distribution | |
| DS1016-10 | In distribution | |
| 2045-01 | In distribution | |
| HS1003-10 | In distribution | |
| 2001-02 | In distribution | |
| 6-611A-02 | In distribution | |
| 2041-01 | In distribution | |
| 2027-02 | In distribution | |
| 2035-02 | In distribution | |
| 2044-07 | In distribution | |
| 2041-03 | In distribution | |
| HS1003-14 | In distribution | |
| 6-603A-03 | In distribution | |
| 2007-09 | In distribution | |
| 2021-13 | In distribution | |
| 2004-04 | In distribution | |
| 2004-03 | In distribution | |
| A150007 | In distribution | |
| DS1016-14 | In distribution | |
| 6-610A-05 | In distribution | |
| 2039-99 | In distribution | |
| 504F10 | In distribution | |
| 6-614A-98 | In distribution | |
| 2038-02 | In distribution | |
| 2042-02 | In distribution | |
| 2032-03 | In distribution | |
| 697F10 | In distribution | |
| 2042-01 | In distribution | |
| 2020-01 | In distribution | |
| 2021-02 | In distribution | |
| 6-613A-03 | In distribution | |
| 2035-04 | In distribution | |
| 1178MLPP | In distribution | |
| 6-603A-04-POC | In distribution | |
| 2033-04 | In distribution | |
| A150005 | In distribution | |
| 2007-01 | In distribution | |
| 604F10 | In distribution | |
| 6-615A-05 | In distribution | |
| 2045-03 | In distribution | |
| 2044-02 | In distribution | |
| 2039-04 | In distribution | |
| 6-608A-02 | In distribution | |
| 6-603A-03-POC | In distribution | |
| 6-608A-98 | In distribution | |
| 6-604A-05-POC | In distribution | |
| 2004-00 | In distribution | |
| 2027-03 | In distribution | |
| 6-602A-05 | In distribution | |
| 6-610A-03 | In distribution | |
| HS1005-10 | In distribution | |
| 2005-00 | In distribution | |
| 6-612A-02 | In distribution | |
| 2001-05 | In distribution | |
| 2001-00 | In distribution | |
| 2020-11 | In distribution | |
| 2005-02 | In distribution | |
| 2020-04 | In distribution | |
| 606F10 | In distribution | |
| 2007-04 | In distribution | |
| 2042-08 | In distribution | |
| DS1016-16 | In distribution | |
| 6-607A-02 | In distribution | |
| 2005-03 | In distribution | |
| A152306 | In distribution | |
| 6-612A-04 | In distribution | |
| 2033-02 | In distribution | |
| 6-600A-05 | In distribution | |
| 2032-01 | In distribution | |
| 6-601A-03 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Health Design Polycast Cast Boot | Darco International, Inc. | 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.