Vizient Novaplus
Body Holder, OR Table Safety
28manufacturers in China registered for this device type
2catalogue 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 | 2021-07-28 |
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 12, case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VM9352-D | In distribution | |
| VM5173E | In distribution |
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 |
| DeRoyal | Deroyal Industries, Inc. | 251 |
| 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 |
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
3 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 |
|---|---|---|---|---|---|
| 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 |
| 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.