TDX SP2 With LiNX Electronics
The TDX SP2 with LiNX Electronics is a battery-powered wheelchair with centre-wheel drive. Its rigid, nonfolding base uses two drive motors, front and rear casters and the LiNX control…
The TDX SP2 with LiNX Electronics is a battery-powered wheelchair with centre-wheel drive. Its rigid, nonfolding base uses two drive motors, front and rear casters and the LiNX control system to provide powered mobility.
The updated control system includes a touch interface and wireless functions. A user can operate a computer cursor through compatible joystick controls, while a separate diagnostic function sends wheelchair-electronics status to a supported mobile device.
Power and Configuration
Two 12-volt batteries power the drive system. The TDXSP2 subject model is distinct from the separately listed single- and multiple-actuator Ultra Low Maxx base configurations.
62manufacturers in China registered for this device type
1catalogue number
38510(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 | Invacare GmbH, Germany |
|---|---|
| FDA product code | ITI |
| Device type | Wheelchair, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3860 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K170507 |
| Record published | 2017-08-14 |
| Record revised | 2026-02-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature -25 to 50 °C; Handling environment humidity 0 to 90 % RH; Storage environment humidity 0 to 90 % RH; Storage environment temperature -40 to 65 °C |
| Distribution end date | 2023-10-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TDXSP2 | 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 |
|---|---|
| K202379 | 2021-03-19 |
| K192216 | 2020-01-02 |
| K182946 | 2018-12-11 |
| K170507 | 2017-07-12 |
| K141783 | 2015-01-09 |
| K073134 | 2007-11-16 |
| K033819 | 2004-06-04 |
| K023589 | 2002-11-19 |
| K021680 | 2002-06-18 |
| K013516 | 2001-12-13 |
| K012909 | 2001-10-24 |
| K012927 | 2001-09-19 |
| K010364 | 2001-03-22 |
| K002157 | 2000-08-25 |
| K001777 | 2000-07-24 |
| K993413 | 1999-12-15 |
| K991119 | 1999-08-19 |
| K991168 | 1999-06-25 |
| K982064 | 1998-10-05 |
| K950724 | 1995-08-07 |
| K940972 | 1994-06-02 |
| K940051 | 1994-03-28 |
| K930676 | 1994-03-25 |
| K914938 | 1992-01-13 |
| K900565 | 1990-02-15 |
| K885261 | 1989-03-15 |
| K885212 | 1989-03-15 |
| K880360 | 1988-09-19 |
| K880361 | 1988-09-19 |
| K880362 | 1988-09-19 |
| K880364 | 1988-09-19 |
| K880365 | 1988-09-19 |
| K880363 | 1988-09-19 |
| K863250 | 1986-08-29 |
| K854164 | 1986-01-13 |
| K852811 | 1985-08-22 |
| K852813 | 1985-08-22 |
| K852810 | 1985-08-22 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Invacare GmbH | 510(k) number | 2022-03-30 | Class II | Device Design | The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery ha | 133 devices |
| Invacare GmbH | 510(k) number | 2021-11-12 | Class II | Software design | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential i | 1477 units US; 1226 units OUS |
Recalls
8 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 |
|---|---|---|---|---|---|
| 2021-11-12 | Class II | Software design | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential i | 303 units US; 20 units OUS | |
| 2021-11-12 | Class II | Software design | Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential i | 1 unit US | |
| 2015-01-15 | Class II | Device Design | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if | 525 | 2015-09-23 |
| 2015-01-15 | Class II | Device Design | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if | 1942 | 2015-09-23 |
| 2015-01-15 | Class II | Device Design | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if | 60 | 2015-09-23 |
| 2014-06-24 | Class II | Process control | M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max | 819 | 2014-10-15 |
| 2013-06-04 | Class II | Process control | Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks. | 166,230 | 2016-01-04 |
| 2012-04-06 | Class II | Employee error | Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which wo | 665 affected power wheel chairs and 15 post-fuse assembly se | 2014-05-20 |
| 2009-09-15 | Not classified | Device Design | For some Invacare chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock f | 36 | 2014-08-25 |
| 2007-11-27 | Not classified | Pending | Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may veer to one side or it may rock forward onto | 4171 Wheelchairs | 2013-08-01 |
| 2003-12-15 | Not classified | Other | The weld joints on the seat back may fail and cause possible injury to the patient. | 5,990 units | 2008-09-13 |
| 2003-12-15 | Not classified | Other | The weld joints on the seat back may fail and cause possible injury to the patient. | 5,990 units | 2008-09-13 |
| 2003-12-15 | Not classified | Other | The weld joints on the seat back may fail and cause possible injury to the patient. | 5,990 units | 2008-09-13 |
| 2003-03-10 | Not classified | Other | A short circuit within the charger harness may cause heat damage to the units with potential for fire. | 20,956 units | 2012-04-13 |
| 2003-02-10 | Not classified | Other | A short circuit within the charger harness may cause heat damage to the units with potential for fire. | 5,029 scooters | 2012-04-12 |
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.