Guardian Splint
This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.
Who Else Makes It
Concentrated in Guangdong (14), Jiangsu (12), Hebei (11). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Hengshui Tianjian Medical Supplies Co., Ltd. | Shenzhou | Hebei | Contract manufacturer | 14 |
| Hubei Dacheng Medical Technology Co., Ltd. | Xianning | Hubei | Contract manufacturer | 12 |
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 12 |
| Dongguan Vigor Textile Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
Showing 12 of 62. All 62 manufacturers in China registered for Splint, Extremity, Non-Inflatable, External, Non-Sterile
Record
| Listed by | BM Korea Co., Ltd., South Korea |
|---|---|
| FDA product code | NOC |
| Device type | Splint, Extremity, Non-Inflatable, External, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3910 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 300 to 710 mm; width 100 to 125 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GLLC | Length 430 mm | In distribution |
| GSL-L | Length 355 mm | In distribution |
| GLA | Length 580 mm | In distribution |
| GSL-S | Length 300 mm | In distribution |
| GLL | Length 710 mm | In distribution |
| GSL-M | Length 330 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Morrison Medical | Morrison Corporation | 107 |
| SAM Splint | SAM Medical Products | 31 |
| Redi Splint | Faretec, Inc. | 22 |
| Spencer | Spencer Italia SRL | 20 |
| Body Armor® Stirrup Walker | Darco International, Inc. | 20 |
| Kentex | Kentron Healthcare, Inc. | 16 |
| Darco® Relief Insert™ Walker | Darco (Europe) GmbH | 14 |
| Darco® FX Pro™ Walker | Darco International, Inc. | 10 |
| Darco® FXPro Walker Liner | Darco International, Inc. | 10 |
| Darco® Body Armor® Walker II | Darco International, Inc. | 10 |
| Darco® Posterior Splint | Darco (Europe) GmbH | 9 |
| Kentec ArmBoard | Kentec Medical, LLC | 6 |
Showing 12 of 66. All products under Splint, Extremity, Non-Inflatable, External, Non-Sterile
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.