Spex Limited
Spex PROMO-ATPKIT-18 A standardised Assistive Technology Professional Accessory Kit - Adult (18") Includes 1275-0044-000 Spex Extended Lateral Head Support Head Support pad (000 Black)…
Spex PROMO-ATPKIT-18 A standardised Assistive Technology Professional Accessory Kit – Adult (18″) Includes 1275-0044-000 Spex Extended Lateral Head Support Head Support pad (000 Black) 1266-3046-400 Axial Biangular Lateral Pad Size 6, with 12mm Pressure Reduction padding, Standard cover 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 Head Support 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. 1266-3046-400 Axial Biangular Lateral Pad Size 6, 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
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.
| 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
| 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 | 2025-03-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1267-3614-800 | In distribution | |
| 1102-1800-33SC | In distribution | |
| 1266-3031-500 | In distribution | |
| 1266-3024-500 | In distribution | |
| 1266-3023-600 | In distribution | |
| 1266-3023-500 | In distribution | |
| 1267-3635-800 | In distribution | |
| 1266-3033-600 | In distribution | |
| 1266-3014-500 | In distribution | |
| 1266-3012-500 | In distribution | |
| 1266-3034-600 | In distribution | |
| 1266-3032-600 | In distribution | |
| 1266-3024-600 | In distribution | |
| 1267-3634-800 | In distribution | |
| 1267-3610-800 | In distribution | |
| 1266-3011-500 | In distribution | |
| 1266-3010-500 | In distribution | |
| 1102-1800-33HC | In distribution | |
| 1266-3031-600 | In distribution | |
| 1267-3632-800 | In distribution | |
| 1274-1232-000 | In distribution | |
| 1266-3022-500 | In distribution | |
| 1266-2501-100 | In distribution | |
| 1266-3036-600 | In distribution | |
| 1266-3032-500 | In distribution | |
| 1266-3010-600 | In distribution | |
| 1266-2450-100 | In distribution | |
| 1267-3852-800 | In distribution | |
| 1266-3014-600 | In distribution | |
| 1267-3611-800 | In distribution | |
| 1267-3613-800 | In distribution | |
| 1102-1600-33SS | In distribution | |
| 1266-3034-500 | In distribution | |
| 1267-3612-600 | In distribution | |
| 1266-3036-500 | In distribution | |
| 1266-3013-500 | In distribution | |
| PROMO-ATPKIT-18 | In distribution | |
| 1274-2282-000 | In distribution | |
| 1266-3022-600 | In distribution | |
| 1267-3636-800 | In distribution | |
| 1102-1600-33SC | In distribution | |
| 1266-3021-600 | In distribution | |
| 1266-3011-600 | In distribution | |
| 1266-3013-600 | In distribution | |
| 1102-1600-33HC | In distribution | |
| 1266-2201-100 | In distribution | |
| 1267-3633-800 | In distribution | |
| 1266-3012-600 | In distribution | |
| 1266-2420-100 | In distribution | |
| 1274-1282-000 | In distribution | |
| 1267-3612-800 | In distribution | |
| 1266-3033-500 | In distribution | |
| 1266-3035-500 | In distribution | |
| 1102-2020-SSS | In distribution | |
| 1267-3631-800 | In distribution | |
| 1266-3035-600 | In distribution | |
| 9420051709683 | In distribution | |
| 1267-3644-600 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Condor | Grainger International, Inc. | 65 |
| Spex | Spex Ltd | 59 |
| 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.