Atec A.R.M.

Pneumatic Actuation and Regulation System 2.0

Registry build 21.09.26
11manufacturers in China registered for this device type
13catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (1), Anhui (1).

Chinese manufacturers registered for FDA product code FQO
Manufacturer City Province Registered as Device types
Jiangsu Saikang Medical Equipment Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 34
Jiangsu Yongfa Medical Equipment Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 33
Shanghai NO. 2 Medical College Duhang Medical Equipment Factory Shanghai Shanghai Contract manufacturer 32
Jiangsu Rooe Medical Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 31
Hefei MT Medical Co., Ltd. Hefei Anhui Manufacturer 23
Jiangsu Keling Medical Appliances Co., Ltd. Yangzhou Jiangsu Contract manufacturer 23
Hebei Jiede Medical Equipment Co., Ltd. Hengshui Hebei Contract manufacturer 20
Suzhou Number WIN Medical Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 16
Shandong Deman Medical Equipment Group Co., Ltd. Jining Shandong Manufacturer 11
Nanchang Micare Medical Equipment Co., Ltd. Nanchang Jiangxi Manufacturer 8
Nanjing Mindray BIO-Medical Electronics Co., Ltd. Nanjing Jiangsu Manufacturer 2

Record

Regulatory record for Atec A.R.M.
Listed by Alphatec Spine, Inc., United States
FDA product code FQO
Device type Table, Operating-Room, Ac-Powered
Device class Class 1
Regulation 21 CFR 878.4960
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2025-12-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Atec A.R.M.
Catalogue number Size Status
202-210-06 In distribution
102-110-01 In distribution
202-210-01 In distribution
202-900 In distribution
202-310-01 In distribution
202-100 In distribution
102-160 In distribution
202-160-S In distribution
202-120 In distribution
102-100 In distribution
202-210-04 In distribution
102-120 In distribution
202-310-02 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HarmonyAIR Steris Corporation 452
Skytron Skytron, LLC 200
Table, Operating-Room, Ac-Powered Steris Corporation 165
iCE boom and Pendant Amico Clinical Solutions 102
Mindray Nanjing Mindray BIO-Medical Electronics Co., Ltd. 95
Amtai Amtai Medical Equipment, Inc. 95
Steris Steris Corporation 72
Alyon Steris Corporation 41
Foot switch Maquet Gmbh 23
Amsco Steris Corporation 14
Universal table top Maquet Gmbh 13
Magnus operating table system Maquet Gmbh 8

Showing 12 of 442. All products under Table, Operating-Room, Ac-Powered

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