DeRoyal
Elbow Positioner, Immobilizer
28manufacturers in China registered for this device type
251catalogue numbers in this listing
15510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (11), Zhejiang (4), Guangdong (4). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Dongguan Vincent Rehab Devices Company Limited | Dongguan | Guangdong | Contract manufacturer | 11 |
| Viecura Medical Group Limited | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangyin City Ruirun Clothing Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Yangzhou Changqingshu Sports Goods Co., Ltd. | Jiangdu, Yangzhou | Jiangsu | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
Showing 12 of 28. All 28 manufacturers in China registered for Restraint, Protective
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | FMQ |
| Device type | Restraint, Protective |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6760 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-03 |
| Record revised | 2026-03-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 12, case of 50, case of 36, case of 6, case of 20, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M41401 | In distribution | |
| M1131 | In distribution | |
| M1017-UBNQR | In distribution | |
| 203P20 | In distribution | |
| M311-M | In distribution | |
| M211P-L | In distribution | |
| M2030 | In distribution | |
| M41402 | In distribution | |
| M2018L | In distribution | |
| M1017-BC | In distribution | |
| M311-L | In distribution | |
| M611V-M | In distribution | |
| M227-L | In distribution | |
| M240-XL | In distribution | |
| M711-S | In distribution | |
| M117-M | In distribution | |
| M2042 | In distribution | |
| M7025 | In distribution | |
| 197P11 | In distribution | |
| M7035-S | In distribution | |
| M1017-UBQR | In distribution | |
| M7029 | In distribution | |
| M1117D-L | In distribution | |
| MF117-M | In distribution | |
| M8120 | In distribution | |
| M1017-UB | In distribution | |
| M20116 | In distribution | |
| M2025F-L | In distribution | |
| M9233 | In distribution | |
| M8124 | In distribution | |
| M2031B | In distribution | |
| M2035 | In distribution | |
| M2023V-A | In distribution | |
| M8125 | In distribution | |
| M227B-L | In distribution | |
| M911-S | In distribution | |
| M1019-U | In distribution | |
| M228-L | In distribution | |
| M2061 | In distribution | |
| 206P40 | In distribution | |
| M2026V | In distribution | |
| M228B-M | In distribution | |
| M311-S | In distribution | |
| M2042NR | In distribution | |
| M2023S | In distribution | |
| M1117-L | In distribution | |
| M611V-L | In distribution | |
| M8035-I | In distribution | |
| MF117-S | In distribution | |
| M9610-XL | In distribution | |
| M2041 | In distribution | |
| M20117 | In distribution | |
| 400P40 | In distribution | |
| M112B-L | In distribution | |
| M8122-XS | In distribution | |
| M227-XXL | In distribution | |
| M20114 | In distribution | |
| M2042S | In distribution | |
| M2018S | In distribution | |
| M2011D-U | In distribution | |
| M1117D-S | In distribution | |
| M2025R-S | In distribution | |
| M211-M | In distribution | |
| M2042BA | In distribution | |
| M227-M | In distribution | |
| 204P10 | In distribution | |
| M8116 | In distribution | |
| M8035-C | In distribution | |
| M2570D01 | In distribution | |
| M227B-XXL | In distribution | |
| 199P10 | In distribution | |
| M5137-M | In distribution | |
| M2042-B | In distribution | |
| M8139 | In distribution | |
| M5137-L | In distribution | |
| 100P10 | In distribution | |
| M8035-L | In distribution | |
| M223-S | In distribution | |
| M117-L | In distribution | |
| M2032 | In distribution | |
| M2029 | In distribution | |
| 103P10 | In distribution | |
| M7028 | In distribution | |
| M711-M | In distribution | |
| M2026 | In distribution | |
| 203P10 | In distribution | |
| M5137-XL | In distribution | |
| M7023 | In distribution | |
| M2025R-M | In distribution | |
| M7035-L | In distribution | |
| M1117D-M | In distribution | |
| M228B-L | In distribution | |
| M240-S | In distribution | |
| M2039 | In distribution | |
| M222-XL | In distribution | |
| M20113 | In distribution | |
| M227-XL | In distribution | |
| M117-XL | In distribution | |
| 102P10 | In distribution | |
| M7035-XL | In distribution | |
| M2023-I | In distribution | |
| M1018-U | In distribution | |
| M117-S | In distribution | |
| M9400 | In distribution | |
| M8123-XS | In distribution | |
| M1017-U | In distribution | |
| M227B-XL | In distribution | |
| M228B-XXL | In distribution | |
| 205P20 | In distribution | |
| M20114-B | In distribution | |
| M2023-A | In distribution | |
| M2050 | In distribution | |
| M20115 | In distribution | |
| M223-L | In distribution | |
| M8135 | In distribution | |
| M7035-SB | In distribution | |
| M2023B | In distribution | |
| M8035-M | In distribution | |
| M228-XXL | In distribution | |
| M112-XL | In distribution | |
| M1018-V | In distribution | |
| M711-L | In distribution | |
| M911-L | In distribution | |
| M2049 | In distribution | |
| M112B-XL | In distribution | |
| M112-M | In distribution | |
| M222-L | In distribution | |
| 207P20 | In distribution | |
| M2011R-U | In distribution | |
| M1117-M | In distribution | |
| M223-XXL | In distribution | |
| 72-6100 | In distribution | |
| 72-6101 | In distribution | |
| M2621D01 | In distribution | |
| M222-XXL | In distribution | |
| M240-XXXL | In distribution | |
| M2012D-U | In distribution | |
| 32-2064 | In distribution | |
| 100P40 | In distribution | |
| M2028-P | In distribution | |
| M2033 | In distribution | |
| M7020D-I | In distribution | |
| M228-XL | In distribution | |
| M8139-P | In distribution | |
| 105P10 | In distribution | |
| M228B-XL | In distribution | |
| M222-S | In distribution | |
| M1017-UNQR | In distribution | |
| M8137 | In distribution | |
| M8035-P | In distribution | |
| M2052 | In distribution | |
| M2036-U | In distribution | |
| M7033 | In distribution | |
| M240-M | In distribution | |
| M1020-U | In distribution | |
| M7034D-C | In distribution | |
| M9610-S | In distribution | |
| 206P20 | In distribution | |
| M2025F-M | In distribution | |
| M117DB-S | In distribution | |
| M8123 | In distribution | |
| M5178 | In distribution | |
| M240-L | In distribution | |
| 100P20 | In distribution | |
| 204P20 | In distribution | |
| M8138 | In distribution | |
| M112B-S | In distribution | |
| 205P40 | In distribution | |
| M611V-S | In distribution | |
| M9401 | In distribution | |
| M8117 | In distribution | |
| M2025R-L | In distribution | |
| M2017-U | In distribution | |
| M7030D-C | In distribution | |
| M8118 | In distribution | |
| M2025 | In distribution | |
| M1017-UQR | In distribution | |
| M227B-S | In distribution | |
| M211P-S | In distribution | |
| M228-S | In distribution | |
| 204P40 | In distribution | |
| M2027 | In distribution | |
| M2027-A | In distribution | |
| M5173 | In distribution | |
| 72-6103 | In distribution | |
| 197P10 | In distribution | |
| M2025F-S | In distribution | |
| M112B-XXL | In distribution | |
| M5115 | In distribution | |
| 205P10 | In distribution | |
| M8128 | In distribution | |
| M7035-XS | In distribution | |
| 207P40 | In distribution | |
| M9610-M | In distribution | |
| 100P30 | In distribution | |
| 5-1103A-00 | In distribution | |
| 32-1990 | In distribution | |
| M112-S | In distribution | |
| M2034 | In distribution | |
| M9610-L | In distribution | |
| M8018S | In distribution | |
| M2013-U | In distribution | |
| M222-M | In distribution | |
| 203P40 | In distribution | |
| M112-L | In distribution | |
| M2031 | In distribution | |
| M2011D-UB | In distribution | |
| M5137-S | In distribution | |
| M112B-M | In distribution | |
| M223-XXXL | In distribution | |
| M611V-XXL | In distribution | |
| M2016-U | In distribution | |
| M240-XXL | In distribution | |
| M211P-XL | In distribution | |
| M227-S | In distribution | |
| M2023-C | In distribution | |
| M9234 | In distribution | |
| M228-M | In distribution | |
| M2042-M | In distribution | |
| M2013B-U | In distribution | |
| M8136 | In distribution | |
| M7024 | In distribution | |
| M8035-S | In distribution | |
| M711-XL | In distribution | |
| MF117-L | In distribution | |
| M211P-M | In distribution | |
| M7035-M | In distribution | |
| M9113 | In distribution | |
| M211P-XXL | In distribution | |
| M7025-14 | In distribution | |
| M8122-B | In distribution | |
| M2014-U | In distribution | |
| 206P10 | In distribution | |
| 104P10 | In distribution | |
| M5173L | In distribution | |
| M228B-S | In distribution | |
| M9352-D | In distribution | |
| M911-M | In distribution | |
| M611V-XL | In distribution | |
| M227B-M | In distribution | |
| M2028 | In distribution | |
| M211-L | In distribution | |
| M711-XXL | In distribution | |
| M211-S | In distribution | |
| M8122 | In distribution | |
| M5172 | In distribution | |
| M4114 | In distribution | |
| M2570D11 | In distribution | |
| M223-M | In distribution | |
| M223-XL | In distribution |
Showing 250 of 251 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| E.M. Adams Co., Inc. | E.M. Adams Co., Inc. | 1,310 |
| Morrison Medical | Morrison Corporation | 823 |
| Posey | Posey Products, LLC | 91 |
| MTI | Tech Industries. Inc. | 77 |
| iFIX | iSYS Medizintechnik GmbH | 33 |
| McKesson | Mckesson Medical-Surgical Inc. | 27 |
| Procare | DJO, LLC | 27 |
| Salvafix Memory PRO | Medi Care System SLU | 26 |
| Coulmed | Coulmed Products Group LLC | 25 |
| Medline | Medline Industries, Inc. | 19 |
| Salvaclip Safe | Medi Care System SLU | 17 |
| Salvacel | Medi Care System SLU | 16 |
Showing 12 of 109. All products under Restraint, Protective
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K963466 | 1997-02-13 |
| K963468 | 1997-01-22 |
| K963474 | 1997-01-22 |
| K963476 | 1997-01-22 |
| K963467 | 1997-01-03 |
| K963465 | 1996-12-19 |
| K963472 | 1996-11-14 |
| K963471 | 1996-11-14 |
| K963469 | 1996-11-14 |
| K963470 | 1996-11-14 |
| K963473 | 1996-11-14 |
| K963478 | 1996-11-14 |
| K963477 | 1996-11-12 |
| K963464 | 1996-11-12 |
| K963463 | 1996-10-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | UDI-DI | 2022-07-15 | Class II | Under Investigation by firm | The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure. | 36 eaches and 7 pairs | 2024-08-06 |
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 |
|---|---|---|---|---|---|
| 2020-02-27 | Class II | Nonconforming Material/Component | One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device. | 94 pairs | 2022-05-10 |
| 2014-02-21 | Class II | Packaging | Moldy smell in product | 8,962 pairs | 2015-05-08 |
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.