DeRoyal
Elbow Brace, Slimline Hinge Universal
144manufacturers in China registered for this device type
295catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (46), Zhejiang (25), Jiangsu (20). 32 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Suzhou Sunmed Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 28 |
| 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 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Metacare Industrial Ltd | Guangzhou | Guangdong | Contract manufacturer | 17 |
Showing 12 of 144. All 144 manufacturers in China registered for Orthosis, Limb Brace
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | IQI |
| Device type | Orthosis, Limb 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 24, case of 160, case of 200 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-455A-34 | In distribution | |
| NS2000-14 | In distribution | |
| 14534205 | In distribution | |
| 9118-02 | In distribution | |
| 405K10 | In distribution | |
| 1-527A-05 | In distribution | |
| NE7734-73 | In distribution | |
| 5-1103A-06 | In distribution | |
| 14533205 | In distribution | |
| 15580006 | In distribution | |
| 15590006 | In distribution | |
| 9127-03 | In distribution | |
| FB3000-24 | In distribution | |
| 13-807A-01 | In distribution | |
| 14533109 | In distribution | |
| FB5000-18 | In distribution | |
| 14534206 | In distribution | |
| 4229DL | In distribution | |
| 14534109 | In distribution | |
| NE7744-77 | In distribution | |
| NE7734-76 | In distribution | |
| 19-202A-01 | In distribution | |
| 11-456A-12 | In distribution | |
| 13-801A-04 | In distribution | |
| NE7728-76 | In distribution | |
| EU08101-U4 | In distribution | |
| 15590067 | In distribution | |
| 14533207 | In distribution | |
| 15580008 | In distribution | |
| FB2000-16 | In distribution | |
| 5-1102A-05 | In distribution | |
| 5-1100A-00 | In distribution | |
| EU02625-U9 | In distribution | |
| 10-1368 | In distribution | |
| 5-1103A-03 | In distribution | |
| 12850005 | In distribution | |
| 14534107 | In distribution | |
| 12850008 | In distribution | |
| 14515206 | In distribution | |
| 14515105 | In distribution | |
| 9117-01 | In distribution | |
| 5-1102A-06 | In distribution | |
| 19-200A-00 | In distribution | |
| 14514400 | In distribution | |
| 14514200 | In distribution | |
| 4425FL | In distribution | |
| NS2000-21 | In distribution | |
| 405K20 | In distribution | |
| 15590002-CHO | In distribution | |
| FB5000-40 | In distribution | |
| 4125DL | In distribution | |
| 404K11 | In distribution | |
| 4127BL | In distribution | |
| 4127DR | In distribution | |
| NE7728-72 | In distribution | |
| EB2040-00 | In distribution | |
| 14533208 | In distribution | |
| 14533106 | In distribution | |
| 9117-02 | In distribution | |
| NE7727-76 | In distribution | |
| 5-1103A-02 | In distribution | |
| EU02510-U3 | In distribution | |
| 19-202A-03 | In distribution | |
| 14533209 | In distribution | |
| 14533108 | In distribution | |
| EU02510-U4 | In distribution | |
| 5-1102A-04 | In distribution | |
| 19-203A-00 | In distribution | |
| 13-808A-05 | In distribution | |
| 6004-01 | In distribution | |
| 4127BK | In distribution | |
| FB3000-10 | In distribution | |
| FB5000-30 | In distribution | |
| 592-45 | In distribution | |
| 592-23 | In distribution | |
| 4220C | In distribution | |
| NE7727-75 | In distribution | |
| 5-1102A-01 | In distribution | |
| 15590008-CHO | In distribution | |
| 4425R | In distribution | |
| FB5000-38 | In distribution | |
| 14513156 | In distribution | |
| 14534209 | In distribution | |
| FB4000-10 | In distribution | |
| 14514300 | In distribution | |
| 1-516A-04 | In distribution | |
| 1-527A-02-POC | In distribution | |
| 13-808A-06 | In distribution | |
| EU02625-U6 | In distribution | |
| 19-200A-98 | In distribution | |
| NS2000-20 | In distribution | |
| 404K20 | In distribution | |
| 19-202A-02 | In distribution | |
| 12850009 | In distribution | |
| 15590067-CHO | In distribution | |
| 9116-03 | In distribution | |
| 9118-01 | In distribution | |
| EB6000-02 | In distribution | |
| FB1000-10 | In distribution | |
| 9128-01 | In distribution | |
| EU02625-U10 | In distribution | |
| 12850004 | In distribution | |
| KB6000-01 | In distribution | |
| NE7731-74 | In distribution | |
| 4127CK | In distribution | |
| 13-808A-02 | In distribution | |
| 4425PKL | In distribution | |
| FB5000-12 | In distribution | |
| NE7727-72 | In distribution | |
| FB3000-22 | In distribution | |
| SC2000-12 | In distribution | |
| NE7731-75 | In distribution | |
| 5-1102A-02 | In distribution | |
| 14514100 | In distribution | |
| EU02510-U8 | In distribution | |
| NE7734-74 | In distribution | |
| NE7734-75 | In distribution | |
| EU02625-U7 | In distribution | |
| NE7728-74 | In distribution | |
| NE7731-72 | In distribution | |
| 5-1103A-01 | In distribution | |
| 5-1102A-03 | In distribution | |
| NE7744-75 | In distribution | |
| 15590006-CHO | In distribution | |
| FB3000-16 | In distribution | |
| 14513134 | In distribution | |
| FB2000-14 | In distribution | |
| FB5000-16 | In distribution | |
| FB3000-12 | In distribution | |
| EU02510-U7 | In distribution | |
| EU02510-U6 | In distribution | |
| 4125CR | In distribution | |
| 1-527A-04-POC | In distribution | |
| NE7734-71 | In distribution | |
| 12870000 | In distribution | |
| 5-1103A-08 | In distribution | |
| 5-1103A-07 | In distribution | |
| 15580067 | In distribution | |
| 4425PKR | In distribution | |
| EU02625-U3 | In distribution | |
| 4229CL | In distribution | |
| 4229CLK | In distribution | |
| 13-806A-02 | In distribution | |
| 13-807A-04 | In distribution | |
| 4125DR | In distribution | |
| 15590005-CHO | In distribution | |
| 4425FR | In distribution | |
| EU08101-U8 | In distribution | |
| NE7728-71 | In distribution | |
| FB5000-34 | In distribution | |
| FB1000-14 | In distribution | |
| NS2000-10 | In distribution | |
| 11-456A-34 | In distribution | |
| 14534106 | In distribution | |
| 6004-03 | In distribution | |
| 5-1104A-00 | In distribution | |
| NE7727-74 | In distribution | |
| 1-527A-02 | In distribution | |
| 13-807A-03 | In distribution | |
| 4127CR | In distribution | |
| 1-527A-03 | In distribution | |
| 9127-01 | In distribution | |
| 4229CR | In distribution | |
| EU08101-U5 | In distribution | |
| 19-201A-00 | In distribution | |
| NE7728-73 | In distribution | |
| NE7734-72 | In distribution | |
| EU2511-U1 | In distribution | |
| 13-807A-02 | In distribution | |
| 15590005 | In distribution | |
| 9128-03 | In distribution | |
| FB2000-12 | In distribution | |
| 14515108 | In distribution | |
| 4127CL | In distribution | |
| 403K11 | In distribution | |
| 14513234 | In distribution | |
| 4220B | In distribution | |
| 4425L | In distribution | |
| KB6000-00 | In distribution | |
| 7119-00 | In distribution | |
| 10-1367 | In distribution | |
| 9117-03 | In distribution | |
| AB2360-00 | In distribution | |
| 6004-04 | In distribution | |
| 19-203A-98 | In distribution | |
| 11-456A-56 | In distribution | |
| 4229DLK | In distribution | |
| 14534108 | In distribution | |
| 15590008 | In distribution | |
| FB3000-20 | In distribution | |
| 9128-02 | In distribution | |
| NE7744-76 | In distribution | |
| NE7730-70 | In distribution | |
| 4125CL | In distribution | |
| 1-512A-01-POC | In distribution | |
| 9116-01 | In distribution | |
| 13-808A-04 | In distribution | |
| SC2000-10 | In distribution | |
| AB2362-00 | In distribution | |
| FB5000-36 | In distribution | |
| 14534208 | In distribution | |
| FB4000-14 | In distribution | |
| NE7744-73 | In distribution | |
| NS2000-12 | In distribution | |
| 11-455A-56 | In distribution | |
| 14533107 | In distribution | |
| 14515207 | In distribution | |
| 14534105 | In distribution | |
| 19-202A-04 | In distribution | |
| 14533206 | In distribution | |
| 19-202A-05 | In distribution | |
| FB2000-10 | In distribution | |
| 14513212 | In distribution | |
| 13-808A-01 | In distribution | |
| EU08101-U3 | In distribution | |
| 5-1105A-00 | In distribution | |
| FB5000-10 | In distribution | |
| 5-1103A-04 | In distribution | |
| 4127BR | In distribution | |
| NE7744-72 | In distribution | |
| SC2000-14 | In distribution | |
| 6004-02 | In distribution | |
| 12850011 | In distribution | |
| EU08101-U7 | In distribution | |
| EU08101-U6 | In distribution | |
| 15590002 | In distribution | |
| NE7744-74 | In distribution | |
| FB1000-16 | In distribution | |
| 6005-00 | In distribution | |
| 14515208 | In distribution | |
| 15580005 | In distribution | |
| NE7728-75 | In distribution | |
| 13-806A-05 | In distribution | |
| 4425LML | In distribution | |
| 4125CK | In distribution | |
| FB3000-14 | In distribution | |
| 11-455A-12 | In distribution | |
| 15580002 | In distribution | |
| 1-527A-04 | In distribution | |
| FB3000-26 | In distribution | |
| 9118-03 | In distribution | |
| AB2361-00 | In distribution | |
| NE7744-71 | In distribution | |
| EU02625-U5 | In distribution | |
| 13-807A-05 | In distribution | |
| 403K10 | In distribution | |
| 13-806A-04 | In distribution | |
| 1-516A-03 | In distribution | |
| NE7727-73 | In distribution | |
| 4425LMR | In distribution |
Showing 250 of 295 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 984 |
| Thrive Orthopedics | Thrive Orthopedics | 272 |
| Formthotics | Foot Science International, Ltd. | 254 |
| VQ Orthocare | Vision Quest Industries, Inc. | 156 |
| Donjoy Performance | DJO, LLC | 78 |
| Profit | Pantymed S.A. | 73 |
| Procare | DJO, LLC | 63 |
| PediHip | Orthopediatrics, Corp | 60 |
| ComfyHealth | Comfy Health Group Co., Ltd. | 51 |
| Push braces | Nea International B.V. | 48 |
| Soft Stride | Brownmed | 44 |
| BMI | Blake Manufacturing, Inc. | 28 |
Showing 12 of 664. All products under Orthosis, Limb Brace
Recalls
2 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2016-11-07 | Class II | Under Investigation by firm | DeRoyal received complaints of mold on Tennis Elbow Straps. | 791 units | 2022-01-13 |
| 2016-11-07 | Class II | Under Investigation by firm | DeRoyal received complaints of mold on Tennis Elbow Straps. | 56 units | 2022-01-13 |
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.