Guardian Supporter
"This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck. Including casting tape, but excluding those that…
“This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck. Including casting tape, but excluding those that do not provide support or reinforcement.”
Who Else Makes It
Concentrated in Guangdong (35), Jiangsu (18), Zhejiang (17). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Shenzhen City U-Lucky Sporting Goods Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Tops Medical Articles Industries Nantong Inc | Qidong | Jiangsu | Contract manufacturer | 17 |
| Yangzhou Feiyali Sporting Goods Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 15 |
| Dongguan Vincent Rehab Devices Company Limited | Dongguan | Guangdong | Contract manufacturer | 11 |
| Zhejiang Steriger Sports Medicine Technology Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 11 |
| Fenglin Industry Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 10 |
| Dongguan Suscong Healthcare Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
Showing 12 of 110. All 110 manufacturers in China registered for Orthosis, Lumbar
Record
| Listed by | BM Korea Co., Ltd., South Korea |
|---|---|
| FDA product code | IQE |
| Device type | Orthosis, Lumbar |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-12 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 1180 to 1305 mm; width 320 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GCSET-S | Length 1180 mm | In distribution |
| GCSET-XL | In distribution | |
| GLSO-M | Length 1245 mm | In distribution |
| GLSO-S | Length 1215 mm | In distribution |
| GLSO-L | Length 1275 mm | In distribution |
| GLSO-XL | Length 1305 mm | In distribution |
| GCSET-M | Length 1200 mm | In distribution |
| GCSET-L | Length 1220 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 118 |
| Neotech Care | Neotech Care Inc. | 84 |
| Curble Chair | Ablue Co., Ltd. | 42 |
| Copperfit | Ideavillage Products Corp. | 34 |
| Vive | Vive Health LLC | 30 |
| Best Back | Indaco SRL | 28 |
| M-Brace Air | Indaco SRL | 24 |
| Breg | Breg, Inc. | 18 |
| CoreTech | Vive Health LLC | 17 |
| Push braces | Nea International B.V. | 12 |
| Tairuibosi | Tianjin Tairuibosi Medical Appliance Co., Ltd. | 9 |
| Boston Brace | Boston Brace International, Incorporated | 8 |
Showing 12 of 67. All products under Orthosis, Lumbar
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.