Spex

Narrow Straight lateral pad with standard cover, size 4; 115mm high x 240mm deep (when purchased with lateral bracket)

Registry build 21.09.26
10manufacturers in China registered for this device type
59catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Guangdong (3), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IMS
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Kunshan Hi-Fortune Health Products Co., Ltd. Kunshan Jiangsu Contract manufacturer 32
Chiaphua Components (Jiangxi) Limited Yichun Jiangxi Contract manufacturer 23
Feishen Group Co., Ltd. Yongkang Zhejiang Contract manufacturer 22
Guangdong Marshell Electric Vehicle Co., Ltd. Zhaoqing Guangdong Contract manufacturer 22
Merits Healthcare Industries. (Suzhou) Co., Ltd. Jiangsu Jiangsu Contract manufacturer 31
China Wonderland Nurserygoods Co., Ltd. Dongguan Guangdong Manufacturer 18
Permobil (Kunshan) Co., Ltd. Kunshan Jiangsu Manufacturer 18
Viscount HI-Tech (Huizhou) Co., Ltd. Huizhou Guangdong Contract manufacturer 17
Global Fabtech Wheel Chair (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 15

Record

Regulatory record for Spex
Listed by Spex Ltd, New Zealand
FDA product code IMS
Device type Support, Head And Trunk, Wheelchair
Device class Class 1
Regulation 21 CFR 890.3910
Establishment Manufacturer
Premarket notification Exempt
Record published 2022-12-12
Record revised 2024-07-15 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Spex
Catalogue number Size Status
1266-3046-410 In distribution
1275-0042-000 In distribution
1266-3023-400 In distribution
1266-3022-800 In distribution
1275-0044-000_077 In distribution
1266-3048-410 In distribution
1275-0022-000 In distribution
1266-3034-800 In distribution
1275-0062-000 In distribution
1266-3034-400 In distribution
1266-3036-800 In distribution
1266-3035-800 In distribution
1266-2623-400 In distribution
1266-3014-800 In distribution
1266-3014-400 In distribution
1275-0031-000 In distribution
1266-3048-400 In distribution
1266-3012-400 In distribution
1266-2301-100 In distribution
1266-3021-800 In distribution
1275-0012-000 In distribution
1266-3044-400 In distribution
1266-3048-800 In distribution
1266-3044-800 In distribution
1275-0021-000 In distribution
1266-3011-800 In distribution
1266-3010-400 In distribution
1266-3035-400 In distribution
1266-3032-800 In distribution
1266-3013-800 In distribution
1266-3013-400 In distribution
1266-3011-400 In distribution
1266-3022-400 In distribution
1275-0041-000 In distribution
1266-3046-400 In distribution
1275-0011-000 In distribution
1266-3024-800 In distribution
1266-3024-400 In distribution
1266-3036-400 In distribution
1275-0043-000 In distribution
1275-0061-000 In distribution
1266-3033-400 In distribution
1266-3044-810 In distribution
1266-3032-400 In distribution
1266-3046-810 In distribution
1266-3031-800 In distribution
1266-3023-800 In distribution
1266-3044-410 In distribution
1275-0044-000 In distribution
1266-3012-800 In distribution
1266-3031-400 In distribution
1275-0032-000 In distribution
1266-3010-800 In distribution
1266-3046-800 In distribution
1275-0021-000_054 In distribution
1266-3021-400 In distribution
1275-0039-000 In distribution
1266-3033-800 In distribution
1266-3048-810 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Condor Grainger International, Inc. 65
Spex Limited Spex Ltd 58
Emys Tarta Design SRL 27
Nxt 1422791 Ontario Ltd 11
ProFit Therafin Corporation 6
Wenzellite Drive DeVilbiss Healthcare 5
Wenzelite Drive DeVilbiss Healthcare 1
Side Mount Headrest Interface Plate Motion Concepts 1
Chair Recl Flat Back Geriatrc CAT Error ON Price Alimed, LLC 1
Headaloft Headovations, Ltd. 1
Wheelchair Headrest Pride Mobility Products Corp. 1
Whitmyer Sunrise Medical (US) LLC 1

Showing 12 of 16. All products under Support, Head And Trunk, Wheelchair

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