Darco® Body Armor® Night Splint
Standard White
62manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Darco International, Inc., United States |
|---|---|
| FDA product code | NOC |
| Device type | Splint, Extremity, Non-Inflatable, External, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3910 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-08 |
| Record revised | 2025-09-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 4, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BADS | In distribution | |
| BADS-S | 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 |
| Guardian Splint | BM Korea Co., Ltd. | 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.