DeRoyal

Short, Inline Pneumatic WALKER2

Registry build 21.09.26
134manufacturers in China registered for this device type
480catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (34), Jiangsu (27), Zhejiang (20). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITW
Manufacturer City Province Registered as Device types
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Fortune Company Ltd. Huizhou Guangdong Contract manufacturer 23
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Allmay Bodywear (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 21
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Wellpower Sporting Goods Co., Ltd. Dong Guan Guangdong Contract manufacturer 18
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18
Jiangsu Reak Healthy Articles Co., Ltd. Yangzhong Jiangsu Contract manufacturer 18
Henan Huibo Medical Co., Ltd. Nanyang Henan Contract manufacturer 17
Metacare Industrial Ltd Guangzhou Guangdong Contract manufacturer 17

Showing 12 of 134. All 134 manufacturers in China registered for Joint, Ankle, External Brace

Record

Regulatory record for DeRoyal
Listed by Deroyal Industries, Inc., United States
FDA product code ITW
Device type Joint, Ankle, External Brace
Device class Class 1
Regulation 21 CFR 890.3475
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-07-23
Record revised 2022-06-10 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 6, case of 10, case of 8, case of 20
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number Size Status
305F30 In distribution
15500046 In distribution
1-502A-05 In distribution
1-522A-03-COSM In distribution
1-502A-98 In distribution
304F20 In distribution
1-512A-03 In distribution
AB3000-16 In distribution
1-505A-04 In distribution
SL2001-12 In distribution
4303B In distribution
15500044 In distribution
4303D In distribution
1-513A-04 In distribution
303F40 In distribution
4301D In distribution
AB3000-14 In distribution
AB2340-00 In distribution
100F32 In distribution
NE7733-73 In distribution
1-511A-03 In distribution
1-531A-13 In distribution
15500037 In distribution
1-525A-03-OGA In distribution
1-507A-02 In distribution
1-503A-06 In distribution
1-531A-04 In distribution
306F20 In distribution
S815-28209 In distribution
NE7732-74 In distribution
SL5002-03 In distribution
1-501A-02 In distribution
4139KB In distribution
302F30 In distribution
4139KA In distribution
798F10 In distribution
1-500A-00 In distribution
AB2120-20 In distribution
15500031 In distribution
AB2150-10 In distribution
15800006 In distribution
203F10 In distribution
1-524A-03-CHO In distribution
AB2900-20 In distribution
SL8001-37 In distribution
1-524A-02-KCBJ In distribution
AB2120-16 In distribution
1-518A-01 In distribution
15500034-NOVA In distribution
15500043 In distribution
4308B In distribution
CSG53550-D In distribution
4303C In distribution
1-525A-03-KOC In distribution
15780067 In distribution
1-525A-01-POC In distribution
4016-04 In distribution
4016-03 In distribution
NE7732-73 In distribution
1177LPP In distribution
4301E In distribution
15570008 In distribution
306F40 In distribution
705F10 In distribution
1-525A-05-OGA In distribution
302F20 In distribution
4016-02 In distribution
1-525A-02-KOC In distribution
AF1000-03 In distribution
1-524A-03-POC In distribution
1-503A-01 In distribution
AF1000-04 In distribution
1-525A-01-KOC In distribution
1-524A-02-POC In distribution
1-525A-04-CFSM In distribution
1-525A-02-POC In distribution
1-501A-00 In distribution
1-512A-05 In distribution
4307D In distribution
305F20 In distribution
1-524A-04-POC In distribution
15780005 In distribution
100F10 In distribution
15500047 In distribution
1-525A-04-OGA In distribution
AB2801-10 In distribution
AB2140-20 In distribution
SL5002-05 In distribution
1-512A-03-POC In distribution
4004-03 In distribution
AB3100-20 In distribution
SL5002-09 In distribution
15500033-NOVA In distribution
4013-03 In distribution
4007-04 In distribution
205F10 In distribution
AB3000-10 In distribution
AB3100-18 In distribution
1-526A-04 In distribution
1-525A-04-KOC In distribution
1-523A-03 In distribution
AB2120-10 In distribution
4300C In distribution
AB2801-18 In distribution
1-523A-03-COSM In distribution
1030614 In distribution
SL8001-03 In distribution
1-518A-04 In distribution
8761-02 In distribution
AB2801-12 In distribution
AB3000-20 In distribution
AB2150-20 In distribution
1-511A-02 In distribution
1-504A-03 In distribution
15510006 In distribution
15600007 In distribution
AB2341-00 In distribution
1-506A-02 In distribution
4307B In distribution
1-524A-02-CHO In distribution
204F10 In distribution
15500048 In distribution
AB2900-14 In distribution
AF1000-01 In distribution
1-522A-05-COSM In distribution
AB2900-12 In distribution
AB2140-10 In distribution
4300B In distribution
15570004 In distribution
1-513A-02 In distribution
AB2150-14 In distribution
AB2700-54 In distribution
1-522A-02-COSM In distribution
1-503A-03 In distribution
1-524A-02 In distribution
NE7732-75 In distribution
15780008 In distribution
1-523A-02 In distribution
1-512A-02-POC In distribution
CSG53550-A In distribution
NE7732-76 In distribution
SL2001-16 In distribution
1-522A-02 In distribution
15600009 In distribution
AB2150-12 In distribution
AF1001-06 In distribution
1-514A-01 In distribution
1-522A-03 In distribution
NE7732-72 In distribution
4306C In distribution
406F12 In distribution
CSG53520-B In distribution
15600006 In distribution
4004-02 In distribution
AB2700-52 In distribution
1-523A-01 In distribution
4007-01 In distribution
1020614 In distribution
1-507A-03 In distribution
1177SPP In distribution
4013-02 In distribution
706F10 In distribution
4304B In distribution
4004-04 In distribution
15510007 In distribution
1-510A-03 In distribution
1-515A-34 In distribution
1-523A-01-COSM In distribution
1-524A-01-CFSM In distribution
AF1001-07 In distribution
CSG53510-C In distribution
305F70 In distribution
A152005 In distribution
1-525A-05-CFSM In distribution
AB2700-58 In distribution
AB3000-12 In distribution
4300E In distribution
303F10 In distribution
1-531A-14 In distribution
305F40 In distribution
AB2341-06 In distribution
1-523A-05 In distribution
1-503A-02 In distribution
405F11 In distribution
1-526A-03 In distribution
NE7733-74 In distribution
1-502A-04 In distribution
1-524A-05-POC In distribution
SL5002-01 In distribution
1-525A-01 In distribution
1010614 In distribution
100F20 In distribution
1-519A-01 In distribution
1-503A-04 In distribution
202F10 In distribution
AB2140-14 In distribution
AB2110-10 In distribution
AB2900-16 In distribution
1-510A-06 In distribution
VAB2360-00 In distribution
1-525A-05-KOC In distribution
1-502A-14 In distribution
15560005 In distribution
1170PP In distribution
AB2801-22 In distribution
1-513A-03 In distribution
1-525A-03-POC In distribution
AB2700-16 In distribution
4301B In distribution
AB2801-24 In distribution
1-523A-05-COSM In distribution
1-507A-05 In distribution
15570006 In distribution
1-525A-04 In distribution
1-525A-03 In distribution
1177XLPP In distribution
1-524A-04-CFSM In distribution
1-525A-02-OGA In distribution
AF1001-08 In distribution
1-514A-00 In distribution
15780006 In distribution
15500039 In distribution
1-524A-05-CFSM In distribution
AB2700-56 In distribution
4301C In distribution
AB2900-18 In distribution
15500049 In distribution
1-522A-05 In distribution
4002-02 In distribution
1-525A-01-CFSM In distribution
1172PP In distribution
1-524A-01-CHO In distribution
AB2801-20 In distribution
4139D In distribution
4307C In distribution
1-525A-03-CFSM In distribution
1-524A-02-OGA In distribution
207F10 In distribution
1-502A-13 In distribution
1-525A-02-CFSM In distribution
AB2140-16 In distribution
15560006 In distribution
15800005 In distribution
15500032-NOVA In distribution
SL2001-03 In distribution
AB2801-28 In distribution
1177MPP In distribution
AB2110-12 In distribution
302F10 In distribution
SC1000-00 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medi Medi Manufacturing Inc 209
Elite Orthopaedics Elite Orthopaedics, Inc. 134
CoreTech Vive Health LLC 118
Vive Vive Health LLC 76
Donjoy Performance DJO, LLC 60
ManaMed Manamed LLC 49
Profit Pantymed S.A. 43
Push braces Nea International B.V. 39
Tairuibosi Tianjin Tairuibosi Medical Appliance Co., Ltd. 36
TruCompress Vive Health LLC 35
BMI Blake Manufacturing, Inc. 32
Henry Schein Henry Schein, Inc. 30

Showing 12 of 414. All products under Joint, Ankle, External Brace

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