Bounder
The FDA filing lists BOUNDER Plus 300 among the BOUNDER Series power wheelchair models, matching the listed series variant. The chair provides mobility for people limited to a sitting…
The FDA filing lists BOUNDER Plus 300 among the BOUNDER Series power wheelchair models, matching the listed series variant.
The chair provides mobility for people limited to a sitting position and is controlled through a joystick or equivalent command mode.
Chair Configuration
The filing describes a modular chair that can be configured in multiple versions. This model has two motors, two 12-volt batteries connected in series and an electronic controller, with a seat, footrests, arms, positioning strap and charger.
Who Else Makes It
Concentrated in Zhejiang (23), Jiangsu (14), Guangdong (10). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 31 |
| 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 |
| Viscount HI-Tech (Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 17 |
| Zhejiang Linix Motor Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 4 |
| Jiangsu Bangbang Intelligent Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 2 |
| Jinhua Ruidi Vehicle Industry Co Ltd | Zhejiang | Zhejiang | Contract manufacturer | 2 |
| Suzhou Green Pine Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 32 |
| Zhenjiang Assure Medical Equipment Co Ltd | Zhenjiang | Jiangsu | Contract manufacturer | 18 |
Showing 12 of 62. All 62 manufacturers in China registered for Wheelchair, Powered
Record
| Listed by | 21ST Century Scientific, Inc., United States |
|---|---|
| FDA product code | ITI |
| Device type | Wheelchair, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3860 |
| Establishment | Manufacturer |
| 510(k) | K193599 |
| Record published | 2020-09-24 |
| Record revised | 2024-06-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BOUNDER PLUS 300 | In distribution | |
| BOUNDER 450 | In distribution | |
| BIG BOUNDER 600 | In distribution | |
| BOUNDER 300 | In distribution | |
| BIG BOUNDER 1000 | In distribution | |
| BIG BOUNDER | Withdrawn | |
| BOUNDER 300M | Withdrawn | |
| BOUNDER PLUS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Merits | Merits Health Products, Inc. | 186 |
| e-motion® | Alber Gmbh | 129 |
| Modular Power Positioning System | Motion Concepts | 112 |
| e-fix® | Alber Gmbh | 56 |
| TRZ-CG Power Positioning System | Motion Concepts | 54 |
| Batec | Batec Mobility SL. | 48 |
| Drive | Drive DeVilbiss Healthcare | 47 |
| Invacare® TDX® Power Wheelchair | Invacare GmbH | 43 |
| Drivemedical | Drive DeVilbiss Healthcare | 34 |
| Heartway Medical Products Co., Ltd. | Heartway Medical Products Co., Ltd. | 20 |
| Scout | Burke, Inc. | 20 |
| Power Wheelchair | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | 18 |
Showing 12 of 277. All products under Wheelchair, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193599 | 2020-09-03 |
| K954044 | 1995-10-13 |
| K901210 | 1990-03-26 |
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.