Karma
The Flexx Junior is a pediatric manual wheelchair designed to provide mobility, comfort, and postural support for children with mobility limitations. Available in self-propelled (Model…
The Flexx Junior is a pediatric manual wheelchair designed to provide mobility, comfort, and postural support for children with mobility limitations. Available in self-propelled (Model FLX-J00 with fixed backrest, Model FLX-J50 with foldable backrest) and transit configurations, it is primarily intended for indoor use with limited outdoor capability on smooth surfaces. The wheelchair offers both self-propulsion with 20″ or 22″ quick-release rear wheels and transit propulsion with 14″ quick-release rear wheels. The device supports users weighing up to (165 lbs) 75 kg and is engineered for growth and incorporates adjustable features to accommodate growth.
Who Else Makes It
Concentrated in Jiangsu (19), Guangdong (14), Zhejiang (4). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 32 |
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 31 |
| Trolli King (Holding) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 23 |
| Jiangsu Assure Medical Equipment Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 18 |
| Foshan Shunkangda Medical Tech Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 16 |
| Raise Medical Industries, Inc. | Foshan | Guangdong | Contract manufacturer | 16 |
| Jiaxing Xinyi Medical Instrument Co., Ltd. | Jiashan | Zhejiang | Contract manufacturer | 12 |
| Zhenjiang Kawaza Medical Products Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Pinkang Medical Technology Co Ltd | Danyang | Jiangsu | Contract manufacturer | 8 |
| Fujian Pacific Medical Manufacturing Co., Ltd. | Yunxiao County | Fujian | Contract manufacturer | 6 |
| Xiamen Taft Medical Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 6 |
| Imami Toys Hebei Co., Ltd. | Handan | Hebei | Contract manufacturer | 2 |
Showing 12 of 46. All 46 manufacturers in China registered for Wheelchair, Mechanical
Record
| Listed by | Karma Mobility Co Ltd, Thailand |
|---|---|
| FDA product code | IOR |
| Device type | Wheelchair, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3850 |
| Establishment | Manufacturer |
| 510(k) | K002167 |
| Record published | 2026-02-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Flexx | In distribution | |
| Flexx Junior | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drivemedical | Drive DeVilbiss Healthcare | 329 |
| Drive | Drive DeVilbiss Healthcare | 303 |
| Gendron | GF Health Products, Inc | 158 |
| Everest & Jennings | GF Health Products, Inc | 106 |
| Probasics | Drive DeVilbiss Healthcare | 75 |
| Evermed | Xiamen Taft Medical Co., Ltd. | 48 |
| Convaid | Convaid Products LLC | 46 |
| Karman Healthcare | Karman Healthcare Inc. | 41 |
| Medline | Medline Industries, Inc. | 40 |
| Cardinal Health | Cardinal Health 200, LLC | 38 |
| Dalton Manual Wheelchair | Dalton Technology, Inc. | 37 |
| Merits | Merits Health Products, Inc. | 35 |
Showing 12 of 226. All products under Wheelchair, Mechanical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250576 | 2025-11-04 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Karman Healthcare Inc. | 510(k) number | 2016-01-27 | Class II | Employee error | Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets. | 35 | 2016-06-29 |
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.