DeRoyal
Knee Brace, Slimline Short Fixed
137manufacturers in China registered for this device type
987catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (35), Jiangsu (33), Zhejiang (18). 30 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Hengshui Xukang Medical Appliances Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 21 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Foshan Huafukang Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
Showing 12 of 137. All 137 manufacturers in China registered for Joint, Knee, External Brace
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | ITQ |
| Device type | Joint, Knee, 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 | 2021-07-20 |
| Record revised | 2022-08-30 (version 4) |
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 8, case of 24, case of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-443A-02 | In distribution | |
| 14612007 | In distribution | |
| 11-417A-01 | In distribution | |
| 11-436A-01 | In distribution | |
| 7009-03 | In distribution | |
| 11-421A-06 | In distribution | |
| 1010167 | In distribution | |
| 14012007 | In distribution | |
| 14640005 | In distribution | |
| 11-506A-06 | In distribution | |
| NEP7790-74 | In distribution | |
| 11-420A-02 | In distribution | |
| KB5000-00 | In distribution | |
| 7091-11 | In distribution | |
| 1154MPP | In distribution | |
| 14013009 | In distribution | |
| 14840106 | In distribution | |
| NE7701-73 | In distribution | |
| 14023007 | In distribution | |
| 14630009 | In distribution | |
| 11-421A-01 | In distribution | |
| 7004-01 | In distribution | |
| NEP7790-73 | In distribution | |
| 4462-05 | In distribution | |
| 11-405A-00 | In distribution | |
| 14910006 | In distribution | |
| 100K54 | In distribution | |
| 7001-01 | In distribution | |
| 14910010 | In distribution | |
| 100K24 | In distribution | |
| 8894-06 | In distribution | |
| NE7711-74 | In distribution | |
| 7066-24 | In distribution | |
| 14882007 | In distribution | |
| 11-421A-03 | In distribution | |
| 1050127 | In distribution | |
| NE7778-71 | In distribution | |
| 11-447A-01 | In distribution | |
| V4433-12 | In distribution | |
| 7001-04 | In distribution | |
| 11-410A-00 | In distribution | |
| 11-439A-06 | In distribution | |
| 24303 | In distribution | |
| 11-438A-03 | In distribution | |
| NE7707-73 | In distribution | |
| 4105DK | In distribution | |
| 11-417A-04 | In distribution | |
| 1165PP | In distribution | |
| 11-417A-03 | In distribution | |
| 7008-03 | In distribution | |
| 14582010 | In distribution | |
| 11-448A-01 | In distribution | |
| 23705 | In distribution | |
| 11-449A-06 | In distribution | |
| 1154SPP | In distribution | |
| 14630005 | In distribution | |
| NE7778-73 | In distribution | |
| 11-422A-06 | In distribution | |
| NE7701-03 | In distribution | |
| 14023004 | In distribution | |
| 14013007 | In distribution | |
| NE7701-01 | In distribution | |
| 4405L | In distribution | |
| 4209C | In distribution | |
| A144006 | In distribution | |
| NE7702-72 | In distribution | |
| BF1160917 | In distribution | |
| 7003-02 | In distribution | |
| 9307-05 | In distribution | |
| 7066-26 | In distribution | |
| 14021008 | In distribution | |
| V7062-03 | In distribution | |
| 11-416A-07 | In distribution | |
| 11-446A-01 | In distribution | |
| ER1220917 | In distribution | |
| 1050167 | In distribution | |
| 7047-02 | In distribution | |
| 7003-03 | In distribution | |
| 206K10 | In distribution | |
| 11-437A-04 | In distribution | |
| 11-400A-98 | In distribution | |
| V1200917 | In distribution | |
| 7002-04 | In distribution | |
| V1220917 | In distribution | |
| 11-454A-01 | In distribution | |
| 205K10 | In distribution | |
| 11-420A-04 | In distribution | |
| 14840206 | In distribution | |
| 7041-03 | In distribution | |
| 11-600A-05 | In distribution | |
| 11-421A-05 | In distribution | |
| 14910009 | In distribution | |
| 1169PP | In distribution | |
| NE7707-75 | In distribution | |
| 11-559A-04 | In distribution | |
| 1050227 | In distribution | |
| NE7718-75 | In distribution | |
| 11-449A-01 | In distribution | |
| 7066-34 | In distribution | |
| EU08100-U8 | In distribution | |
| 11-420A-06 | In distribution | |
| 11-416A-06 | In distribution | |
| 11-436A-06 | In distribution | |
| EU04021-U6 | In distribution | |
| 7084-44 | In distribution | |
| NE7702-71 | In distribution | |
| 4405R | In distribution | |
| S7072-02 | In distribution | |
| 11-441A-07 | In distribution | |
| NE7702-75 | In distribution | |
| 4405KR | In distribution | |
| BF7006-01 | In distribution | |
| 11-414A-00 | In distribution | |
| BF7007-03 | In distribution | |
| V4433-22 | In distribution | |
| 14013004 | In distribution | |
| 11-558A-04 | In distribution | |
| NEP779374L | In distribution | |
| 7006-05 | In distribution | |
| 7006-04 | In distribution | |
| 208K30 | In distribution | |
| NEP7790-75 | In distribution | |
| 14011004 | In distribution | |
| 7041-11 | In distribution | |
| 7072-04 | In distribution | |
| 14022009 | In distribution | |
| EU4020-U6 | In distribution | |
| NE7701-74 | In distribution | |
| 14022008 | In distribution | |
| 14612008 | In distribution | |
| A145000 | In distribution | |
| 11-447A-02 | In distribution | |
| EU4011-U5 | In distribution | |
| 11-443A-05 | In distribution | |
| 11-445A-07 | In distribution | |
| 7091-18 | In distribution | |
| 11-552A-00 | In distribution | |
| 1153LPP | In distribution | |
| 7041-01 | In distribution | |
| S7072-04 | In distribution | |
| NEP7790-71 | In distribution | |
| 7066-28 | In distribution | |
| 7041-66 | In distribution | |
| 4461-05 | In distribution | |
| V7062-04 | In distribution | |
| 11-451A-01 | In distribution | |
| 7091-16 | In distribution | |
| KB3000-XL | In distribution | |
| 1154LPP | In distribution | |
| 7066-01 | In distribution | |
| 208K20 | In distribution | |
| 8892-01 | In distribution | |
| NE7701-07 | In distribution | |
| 14012006 | In distribution | |
| 11-453A-04 | In distribution | |
| NE7701-72 | In distribution | |
| 7071-02 | In distribution | |
| 14023009 | In distribution | |
| 7091-17 | In distribution | |
| 11-451A-05 | In distribution | |
| BF4433-19 | In distribution | |
| 1030227 | In distribution | |
| 11-415A-07-POC | In distribution | |
| NE7707-72 | In distribution | |
| 11-417A-05 | In distribution | |
| 11-428A-04 | In distribution | |
| 7041-05 | In distribution | |
| 7071-13 | In distribution | |
| NE7702-73 | In distribution | |
| 100K33 | In distribution | |
| 11-439A-02 | In distribution | |
| 14611010 | In distribution | |
| 100K23 | In distribution | |
| NE7702-06 | In distribution | |
| 8892-03 | In distribution | |
| 11-450A-00 | In distribution | |
| ER1200917 | In distribution | |
| 7084-00 | In distribution | |
| ER4433-12 | In distribution | |
| 7082-00 | In distribution | |
| 11-439A-03 | In distribution | |
| 14840205 | In distribution | |
| 202K20 | In distribution | |
| 8896-03 | In distribution | |
| NEP779376L | In distribution | |
| KB9000-01 | In distribution | |
| NE7701-77 | In distribution | |
| 11-439A-05 | In distribution | |
| 4464-05 | In distribution | |
| 1153XLPP | In distribution | |
| 1155LPP | In distribution | |
| 1190917 | In distribution | |
| ER4433-16 | In distribution | |
| 11-448A-06 | In distribution | |
| 100K13 | In distribution | |
| 11-600A-02 | In distribution | |
| 1159PP | In distribution | |
| 100K09 | In distribution | |
| 4433-04 | In distribution | |
| 7071-12 | In distribution | |
| 11-600A-06 | In distribution | |
| NE7717-73 | In distribution | |
| 11-428A-03 | In distribution | |
| 14023006 | In distribution | |
| NE7718-77 | In distribution | |
| BF7006-04 | In distribution | |
| 23701 | In distribution | |
| 1040247 | In distribution | |
| 14581007 | In distribution | |
| 7063-04 | In distribution | |
| 11-440A-04 | In distribution | |
| 11-454A-02 | In distribution | |
| A146009 | In distribution | |
| 11-401A-00 | In distribution | |
| 11-558A-05 | In distribution | |
| 7043-04 | In distribution | |
| NE7701-04 | In distribution | |
| KB3000-01 | In distribution | |
| 11-559A-02 | In distribution | |
| 7001-05 | In distribution | |
| 7060-02 | In distribution | |
| 100K08 | In distribution | |
| FF4061-00 | In distribution | |
| 11-421A-04 | In distribution | |
| A144000 | In distribution | |
| NE7718-76 | In distribution | |
| BF1220917 | In distribution | |
| 11-449A-05 | In distribution | |
| NE7711-75 | In distribution | |
| KB5000-01 | In distribution | |
| NE7701-06 | In distribution | |
| 7062-03 | In distribution | |
| 1040197 | In distribution | |
| 11-438A-04 | In distribution | |
| 14011009 | In distribution | |
| 100K30 | In distribution | |
| NE7702-04 | In distribution | |
| 14640006 | In distribution | |
| 11-453A-07 | In distribution | |
| 14612005 | In distribution | |
| NE7772-72 | In distribution | |
| 11-441A-01 | In distribution | |
| EU08100-U7 | In distribution | |
| 203K30 | In distribution | |
| 7066-32 | In distribution | |
| 14013008 | In distribution | |
| NE7778-72 | In distribution | |
| 11-422A-04 | In distribution | |
| NE7701-71 | In distribution | |
| NE7722-73 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 413 |
| Vive | Vive Health LLC | 122 |
| Donjoy Performance | DJO, LLC | 107 |
| CoreTech | Vive Health LLC | 105 |
| NON Franchise | DJO, LLC | 61 |
| Gripper Hinged Knee | Medical Specialties, Inc. | 46 |
| ManaMed | Manamed LLC | 46 |
| Profit | Pantymed S.A. | 46 |
| Copperfit | Ideavillage Products Corp. | 42 |
| M-Brace Air | Indaco SRL | 42 |
| Joint, Knee, External Brace | Tetra Medical Supply Corp. | 35 |
| BMI | Blake Manufacturing, Inc. | 34 |
Showing 12 of 507. All products under Joint, Knee, External Brace
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2019-11-21 | Class II | Process control | The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. | 2789 units |
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.