Jazzy Carbon
The Power Wheelchair (N5515B) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated…
The Power Wheelchair (N5515B) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
62manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
17recalls on this code
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 | Pride Mobility Products Corp., United States |
|---|---|
| FDA product code | ITI |
| Device type | Wheelchair, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3860 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2022-07-07 |
| Record revised | 2023-04-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Jazzy Carbon | In distribution |
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 |
|---|---|
| K092961 | 2009-10-23 |
| K052353 | 2005-09-09 |
| K042612 | 2004-10-06 |
| K041346 | 2004-09-08 |
| K011993 | 2001-07-13 |
| K001970 | 2000-09-26 |
Recalls
14 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2026-06-25 | Class II | Under Investigation by firm | If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which | 1102 | |
| 2016-12-01 | Class II | Use error | The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle. | 12,343 chairs | 2020-03-19 |
| 2010-02-01 | Not classified | Other | Improper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. This can cause the wire connector and/or the wire itself | 2014-11-20 | |
| 2010-02-01 | Not classified | Other | Improper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. This can cause the wire connector and/or the wire itself | 2014-11-20 | |
| 2008-04-11 | Not classified | Software design | Software – Watch dog timer feature was disabled. | 4129 | 2009-11-13 |
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.