Universal Waist Holder
The waist holder is intended to be used to limit the movement of the patient's body.
28manufacturers in China registered for this device type
3catalogue numbers in this listing
4510(k) clearances naming this product 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 | Kenad SG Medical, Inc., United States |
|---|---|
| FDA product code | FMQ |
| Device type | Restraint, Protective |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6760 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2023-06-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2023-09-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Patient Protective Waist Holder Adult | Withdrawn | |
| Universal Waist Holder Pediatric | Withdrawn | |
| Patient Protective Waist Holder w/slit | Withdrawn |
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 |
|---|---|
| K963430 | 1996-11-22 |
| K963421 | 1996-11-22 |
| K963422 | 1996-11-22 |
| K962626 | 1996-10-02 |
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.