SAM Splint

Rescue Essentials Splint 18IN Flat Orange/Blue

Registry build 21.09.26
62manufacturers in China registered for this device type
31catalogue 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.

Chinese manufacturers registered for FDA product code NOC
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

Regulatory record for SAM Splint
Listed by SAM Medical Products, 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 Contract manufacturer, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2022-09-01
Record revised 2026-07-15 (version 4)

Specifications

Specifications
MRI safety MR Conditional
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number
Packaging Case of 60, case of 24, case of 100, case of 300, case of 75
Distribution end date 2023-07-17

Catalogue Numbers

Catalogue numbers for SAM Splint
Catalogue number Size Status
SP510-OB-EN In distribution
SP507-CH-EN In distribution
SP527-OB-EN-751 In distribution
SP500-OB-EN In distribution
SP502-CH-EN In distribution
SP506-OB-EN In distribution
SP526-OB-EN-514 In distribution
SP527-OD-EN-563 In distribution
SP504-OB-EN In distribution
SP507-OD-EN In distribution
SP502-OB-EN In distribution
SP507-OB-EN In distribution
SP500-CH-EN In distribution
SP506-CH-EN In distribution
SP527-CH-EN-757 Withdrawn
SP522-OB-EN-769 Withdrawn
SP522-CH-EN-770 Withdrawn
SP526-BC-EN-705 Withdrawn
SP526-CH-EN-745 Withdrawn
SP526-OB-EN-772 Withdrawn
SP527-OB-EN-803 Withdrawn
SP526-OB-EN-715 Withdrawn
SP520-CH-EN-768 Withdrawn
SP526-OB-EN-505 Withdrawn
SP527-OB-EN-804 Withdrawn
SP527-OB-EN-748 Withdrawn
SP520-OB-EN-767 Withdrawn
SP527-OB-EN-562 Withdrawn
SP526-OB-EN-568 Withdrawn
SP527-CH-EN-773 Withdrawn
SP524-OB-EN-771 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Morrison Medical Morrison Corporation 107
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
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer