Spex Limited

Spex Assistive Technology Professional (ATP) Accessory Kit - Paediatric 14" Kit Incudes 1259-2400-100 Spex Back Support Quad Mount Hardware 1266-2501-100 Axial Biangular Lateral Bracket…

Registry build 21.09.26

Spex Assistive Technology Professional (ATP) Accessory Kit – Paediatric 14″ Kit Incudes 1259-2400-100 Spex Back Support Quad Mount Hardware 1266-2501-100 Axial Biangular Lateral Bracket (for use with Axial Biangular Lateral Pad) 1266-2301-100 Spex Swing-Away Lateral Bracket, Axial; includes protective neoprene sleeve 1274-1282-000 Stylo 260 Fixed Extended Mechanism 1250-3955-000 TSS Lite Contouring Kit 1266-3012-400 Narrow Straight lateral pad with standard cover, size 2; 95mm high x 180mm deep 1266-3012-800 Narrow Straight lateral pad with Comfy-cover, size 2; 95mm high x 180mm deep 1266-3044-400 Axial Biangular Lateral Pad Size 4, with 12mm Pressure Reduction padding, Standard cover 1275-0043-000 Spex Standard Lateral Head Support Head Support pad (000 Black) 1400-6692-000 Spex Shoulder Strap Guides/Retainer, Pair

54manufacturers in China registered for this device type
132catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (18), Guangdong (14), Zhejiang (11). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KNN
Manufacturer City Province Registered as Device types
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
Jiangyin Huashi Medical Equipment Co., Ltd. Jiangyin Jiangsu Contract manufacturer 21
Zhenjiang Assure Medical Equipment Co Ltd Zhenjiang Jiangsu Contract manufacturer 18
Jiangsu Yuyue Medical Equipment & Supply Company Limited Jiangsu Jiangsu Contract manufacturer 17
Raise Medical Industries, Inc. Foshan Guangdong Contract manufacturer 16
Permobil Trading (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 8
Three Bears (Jiangsu) Healthcare Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 6
Irest Health Science AND Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 5
Zhejiang Linix Motor Co., Ltd. Dongyang Zhejiang Contract manufacturer 4

Showing 12 of 54. All 54 manufacturers in China registered for Components, Wheelchair

Record

Regulatory record for Spex Limited
Listed by Spex Ltd, New Zealand
FDA product code KNN
Device type Components, Wheelchair
Device class Class 1
Regulation 21 CFR 890.3920
Establishment Manufacturer
Premarket notification Exempt
Record published 2025-03-11
Record revised 2024-07-31 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Spex Limited
Catalogue number Size Status
1255-2929-0SS-C In distribution
1008-1416-QRB In distribution
1255-1623-0SS-C In distribution
1255-1414-0SS-C In distribution
1162-2601-000 In distribution
1255-16XX-300 In distribution
1255-1823-0SS-C In distribution
1255-1414-0SS In distribution
1255-1416-0SS In distribution
1256-1623-0SS-C In distribution
1266-2412-100 In distribution
1255-1720-0SS-C In distribution
1255-1618-0SS-C In distribution
1255-18XX-0SS In distribution
1156-0101-210-L In distribution
1162-1602-000 In distribution
1256-1723-0SS-C In distribution
1256-1720-0SS-C In distribution
1008-1818-QRB In distribution
1255-1823-0SS In distribution
1156-0100-210-L In distribution
1156-5822-410 In distribution
PROMO-ATPKIT-14 In distribution
1256-1616-0SS-C In distribution
1256-1820-0SS-C In distribution
1162-2603-000 In distribution
1256-1616-0SS_060 In distribution
1255-1623-0SS In distribution
1255-2018-0SS-C In distribution
1256-1616-0SS_044 In distribution
1259-2200-100 In distribution
1256-1616-0SS_054 In distribution
1266-2430-100 In distribution
1255-2023-0SS-C In distribution
1156-0101-110-R In distribution
1156-0001-210-L In distribution
1255-18XX-300 In distribution
1156-0300-110-L In distribution
1156-0001-210-R In distribution
1259-2810-200 In distribution
1256-20XX-300 In distribution
1256-1514-0SS-C_090 In distribution
1156-0100-110-L In distribution
1256-1414-0SS-C In distribution
1256-1616-0SS_030 In distribution
1209-2713-300 In distribution
1250-3955-000 In distribution
1156-0301-110-L In distribution
1256-1620-0SS-C In distribution
1156-0001-120 In distribution
1256-2023-0SS-C In distribution
1156-1020-400 In distribution
1255-2020-0SS-C In distribution
1255-1620-0SS-C In distribution
1255-1416-0SS-C In distribution
1256-2929-0SS In distribution
1256-1416-0SS-C In distribution
1256-15XX-300 In distribution
1256-1616-0SS_022 In distribution
1156-0300-110-R In distribution
1256-1616-0SS_028 In distribution
1255-2939-0SS-C In distribution
1255-18XX-0SS-C In distribution
1256-18XX-300 In distribution
1256-16XX-300 In distribution
1255-1820-0SS-C In distribution
1162-2602-000 In distribution
1156-0100-110-R In distribution
1156-0301-110-R In distribution
1255-1718-0SS In distribution
1256-1614-0SS In distribution
1255-1420-0SS-C In distribution
1256-1616-0SS_077 In distribution
1255-1820-0SS In distribution
1255-1723-0SS In distribution
1256-1618-0SS-C In distribution
1256-2939-0SS-C In distribution
1256-1214-0SS_077 In distribution
1256-1818-0SS-C In distribution
1156-0100-210-R In distribution
1256-1418-0SS-C In distribution
1255-1618-0SS In distribution
1255-1718-0SS-C In distribution
1156-0001-110-L In distribution
1255-20XX-300 In distribution
1256-1412-0SS In distribution
1256-1718-0SS-C In distribution
1256-12XX-300 In distribution
1156-0301-210-L In distribution
1255-1720-0SS In distribution
1256-2018-0SS-C In distribution
1255-1723-0SS-C In distribution
1266-2411-100 In distribution
1156-0002-110-R In distribution
1156-0002-110-L In distribution
1255-1418-0SS In distribution
1256-14XX-300 In distribution
1162-2600-000 In distribution
1255-1420-0SS In distribution
1259-2450-100 In distribution
1156-0301-210-R In distribution
1008-1616-QRB In distribution
1008-1618-QRB In distribution
1156-1016-400 In distribution
1255-1418-0SS-C In distribution
1156-0300-210-L In distribution
1259-2405-100 In distribution
1259-2100-100 In distribution
1008-1414-QRB In distribution
1162-1603-000 In distribution
1156-0301-120 In distribution
1256-1420-0SS-C In distribution
1156-0001-220 In distribution
1156-0101-110-L In distribution
1156-0001-110-R In distribution
1256-1616-0SS_090 In distribution
1258-2616-0SS In distribution
1259-2470-100 In distribution
1156-5821-410 In distribution
1255-17XX-0SS In distribution
1156-0300-210-R In distribution
1256-1823-0SS-C In distribution
1156-0101-210-R In distribution
1255-1616-0SS-C In distribution
1255-1818-0SS-C In distribution
1255-1818-0SS In distribution
1255-1616-0SS In distribution
1255-14XX-300 In distribution
1259-2453-100 In distribution
1256-2020-0SS-C In distribution
1255-1620-0SS In distribution
1156-1018-400 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Action® Action Products, Inc. 233
Axiom Ki Mobility 182
mo-Vis MO-VIS BV 123
Medline Medline Industries, Inc. 111
Everest & Jennings GF Health Products, Inc 108
Spex Spex Ltd 70
Drive Drive DeVilbiss Healthcare 36
Evermed Xiamen Taft Medical Co., Ltd. 30
Drivemedical Drive DeVilbiss Healthcare 24
Cardinal Health Cardinal Health 200, LLC 23
CoMoveIT Comoveit 8
Spex Seating Spex Ltd 7

Showing 12 of 159. All products under Components, 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