Purist

Leg Positioning System

Registry build 21.09.26
34manufacturers in China registered for this device type
32catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (12), Hebei (6), Guangdong (5). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BWN
Manufacturer City Province Registered as Device types
Jiangsu Xuhe Medical Technology Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 9
Suzhou Baili Medical Supplies Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Suzhou Dukangning Medical Products Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Hubei Yinkang Medical Equipment Co., Ltd. Xiaogan Hubei Contract manufacturer 8
Ningbo Hecai Medical Equipment Co., Ltd. Ningbo Zhejiang Contract manufacturer 8
Meixin Medical Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 7
Dongguan Ergotron Precision Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 2
Danyang NEW Hope Medical Equipment Co., Ltd. Danyang Jiangsu Manufacturer 38
Jiangsu Saikang Medical Equipment Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 34
Shanghai NO. 2 Medical College Duhang Medical Equipment Factory Shanghai Shanghai Contract manufacturer 32
Jiangsu Rooe Medical Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 31
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28

Showing 12 of 34. All 34 manufacturers in China registered for Table And Attachments, Operating-Room

Record

Regulatory record for Purist
Listed by Adsm
FDA product code BWN
Device type Table And Attachments, Operating-Room
Device class Class 1
Regulation 21 CFR 878.4950
Premarket notification Exempt
Record published 2022-11-28
Record revised 2025-08-08 (version 4)

Specifications

Specifications
MRI safety MR Safe
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Distribution end date 2025-08-05

Catalogue Numbers

Catalogue numbers for Purist
Catalogue number Size Status
6813049 Withdrawn
6813002 Withdrawn
6813114 Withdrawn
6813123B Withdrawn
6813035B Withdrawn
6813402 Withdrawn
6883360B Withdrawn
6813116 Withdrawn
6813049B Withdrawn
6813009B Withdrawn
6813100 Withdrawn
6813117 Withdrawn
6813119 Withdrawn
6813122 Withdrawn
6813035 Withdrawn
6883314B Withdrawn
6813120 Withdrawn
6813009 Withdrawn
6813041 Withdrawn
6813048 Withdrawn
6813040B Withdrawn
6813048B Withdrawn
6883314 Withdrawn
6813130 Withdrawn
6813118 Withdrawn
6813131 Withdrawn
6813037 Withdrawn
6813123 Withdrawn
6813041B Withdrawn
6813037B Withdrawn
6883360 Withdrawn
6813040 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Flexarm Surgical Holders and Positioners Flexbar Machine Corp. 134
StrongArm Surgical Holders and Positioners Flexbar Machine Corp. 91
Table And Attachments, Operating-Room Steris Corporation 50
Custom Medical Specialties, Inc. Custom Assemblies, Inc. 46
Flexarm Plus Surgical Holders and Positioners Flexbar Machine Corp. 32
Head rest Maquet Gmbh 27
Pair of leg plates Maquet Gmbh 25
Arthrex® Arthrex, Inc. 21
Extension plate Maquet Gmbh 15
Back plate Maquet Gmbh 11
Coulmed Coulmed Products Group LLC 10
Seat plate extension Maquet Gmbh 10

Showing 12 of 379. All products under Table And Attachments, Operating-Room

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