SupaChair Powered Wheelchair

K173315 · Eurogreen International, Inc. · ITI · Feb 13, 2018 · Physical Medicine

Device Facts

• Record ID: K173315
• Device Name: SupaChair Powered Wheelchair
• Applicant: Eurogreen International, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Feb 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended Use

The device is a powered wheelchair intended to provide mobility to persons restricted to a sitting position.

Device Story

SupaChair is a battery-powered wheelchair designed for mobility-restricted individuals. It consists of a seat, motor mount, and drive system, capable of breaking down into two pieces for transport. The device uses a Dynamic LiNX LE controller to manage movement, featuring dynamic and electromagnetic braking systems. It is operated by the user via a joystick, with an optional detachable attendant joystick available. The device provides mobility in indoor and outdoor environments. By enabling independent movement, it improves patient quality of life and accessibility. Safety is maintained through standard power wheelchair controls and braking mechanisms.

Clinical Evidence

Bench testing only. The device underwent comprehensive performance and safety testing per ISO 7176 standards (parts 1-15, 21, 25) and IEC 62133 for batteries. Testing confirmed static/dynamic stability, braking efficiency, obstacle climbing, and electrical safety/EMC compliance. No clinical data was required or provided.

Technological Characteristics

Powered wheelchair; 24V 15ah SLA or Lithium battery; Dynamic LiNX LE controller; Dynamic and electromagnetic braking. Materials and construction tested per ISO 7176 series (static/dynamic stability, fatigue strength, obstacle climbing). Dimensions: 850-910mm length, 550-610mm width. Weight capacity: 150kg. Modular design (2 pieces).

Indications for Use

Indicated for persons restricted to a sitting position requiring mobility assistance.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• C.T.M. Homecare Product, Inc. Power Chair Model HS-1500 (K073686)

Submission Summary (Full Text)

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February 13, 2018

Eurogreen International Inc. David Hsieh General Manager No. 48, Lane 220, Sec 1, Fu-Zun Rd., Yuan-Lin Township Chang-Hua County, Taiwan 51055 R.O.C.

Re: K173315

Trade/Device Name: "SupaChair" Powered Wheelchair: Safari, Safari Sport, Mini Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 18, 2017 Received: January 22, 2018

Dear David Hsieh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K173315

#### Device Name

"SupaChair" Powered Wheelchair: Safari, Safari Sport, Mini

Indications for Use (Describe)

The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/10 description: The image shows the word "SupnChair" in a stylized font. The letters are black and the background is white. The letters are connected to each other, and the word is slightly slanted to the right.

510(k) Summary

#### Date: Dec 21, 2017

## 5.1 Applicant Information

| Type of Submission | Original Application- Traditional 510(k) |
|--------------------|---------------------------------------------------------------------------------|
| Applicant Name | EUROGREEN INTERNATIONAL INC. |
| Address | No.48, Ln. 220, Sec. 1, Fuzun Rd., Yuanlin Township,<br>Changhua County, Taiwan |
| Phone | [phone] |
| Fax | [phone] |
| Contact Person | David Hsieh |
| Contact Title | General Manager |
| Contact E-mail | [e-mail] |

## 5.2 Device Description

Intended Use : The device is a powered wheelchair intended to provide mobility to persons restricted to a sitting position.

| Item | Description |
|---------------------|--------------------------------|
| Common Name | Powered Wheelchair |
| Trade Name | "SupaChair" Powered Wheelchair |
| Classification Name | Powered Wheelchair |
| Regulation Number | 890.3860 |
| Product Code | ITI |
| Device Class | Class 2 |
| Model | SAFARI/ SAFARI SPORT/ MINI |

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| Image: Supachair logo | Section 5 | Page 2/9 |
|----------------------------------------------------------------------|------------------------------------------------------------------------------|-------------|
| | 510(k) Summary | |
| Drive wheel size | 200mm (8"), 260mm (10") | |
| Caster wheel size | 100mm (4"), 178mm (7"), 200mm (8") | |
| Overall Length | 850~910mm (33.5~35.8") | |
| Overall Width | 550~610mm (21.7~24") | |
| Overall Height | 800~865mm (31.5~34") | |
| Standard Seat Width | 400~410mm (15.8~16.2") | |
| Standard Seat Depth | 380~400mm (15~15.8") | |
| Backrest height | 320~370mm (12.6~14.6") | |
| Weight capacity | 150kg (330 lbs) | |
| Total weight with batteries<br>(SLA) | 37.7~40kg (83~88 lbs) | |
| Weight of motor mount<br>complete | 17.9~20.5kg (39.4~45 lbs) | |
| Heaviest Piece | 17.9~20.5kg (39.4~45 lbs) | |
| Breaks down into | 2 pieces | |
| Weight of seat (included<br>armrest) | 9.4~10.6kg (20.7~23.4 lbs) | |
| Maximum speed SLA<br>battery | 5.2~9kph (3.2~5.6mph) | |
| Turning Radius | 590~730mm (23.2~28.7") | |
| Ground clearance | 42~105mm (1.6~4.1") | |
| Battery (SLA/Lithium) | 24V 15ah | |
| Weight of battery<br>(SLA/Lithium) | 9.2/4 kg (20/9 lbs) | |
| Slope grade ability | 4~9 degrees | |
| Supachair | Section 5 | Page<br>3/9 |
| | 510(k) Summary | |
| Battery charger SLA | 2A Off board | |
| Battery charger Lithium | 4 A Off board | |
| Armrest height | 200mm (7.9") | |
| Brake | Dynamic braking and electromagnetic brake | |
| Controller | Dynamic LiNX LE | |
| Brake distance-Normal<br>operation<br>(Horizontal-Forward-Max speed) | 1.0-1.5 m/s | |
| Attendant joystick<br>(Optional) | Detachable joystick either mount on power chair or attendant control handle. | |

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| SupChair | Section 5 | Page |
|----------|----------------|-------|
| | 510(k) Summary | 4 / 9 |

| | SAFARI | SAFARI SPORT | MINI |
|--------------------------------------|-----------------------------------------|-------------------------------------|-------------------------------------------|
| Drive wheels size | 200mm (8") | 260mm (10") | 200mm (8") |
| Caster wheels size | 178mm (7") | 200mm (8") | 100mm (4") |
| Overall length | 870mm (34.3") | 910mm (35.8") | 850mm (33.5") |
| Overall width | 600mm (23.6") | 610mm (24") | 550mm (21.7") |
| Overall height | 840mm (33") | 865mm (34") | 800mm (31.5") |
| Standard seat width | 410mm (16.2") | 410mm (16.2") | 400mm (15.8") |
| Standard seat depth | 400mm (15.8") | 400mm (15.8") | 380mm (15") |
| Back rest height | 370mm (14.6") | 370mm (14.6") | 320mm (12.6") |
| Weight capacity | 150kg (330 lbs) | 150kg (330 lbs) | 150kg (330 lbs) |
| Total weight with batteries<br>(SLA) | 37.7kg (83 lbs) | 40kg (88 lbs) | 39.1kg (86 lbs) |
| Weight of motor mount<br>complete | 17.9kg (39.4 lbs) | 20.2kg (44 lbs) | 20.5kg (45 lbs) |
| Heaviest piece | 17.9kg (39.4 lbs) | 20.2kg (44 lbs) | 20.5kg (45 lbs) |
| Breaks down into | 2 pieces | 2 pieces | 2 pieces |
| Weight of seat (included<br>armrest) | 10.6kg (23.4 lbs) | 10.6kg (23.4 lbs) | 9.4kg (20.7 lbs) |
| Maximum speed SLA<br>battery | 6.5kph (4mph) | 9kph (5.6mph) | 5.2kph (3.2mph) |
| Turning radius | 700mm (27.6") | 730mm (28.7") | 590(565)mm/23.2"<br>(22.2") |
| Ground clearance | 70mm (2.76") | 105mm (4.1") | 42mm (1.6") |
| Battery (SLA/Lithium) | 24V 15ah | 24V 15ah | 24V 15ah |
| Weight of battery<br>(SLA/Lithium) | 9.2/4kg (20/9 lbs) | 9.2/4kg (20/9 lbs) | 9.2/4kg (20/9 lbs) |
| Slope grade ability | 9 degree | 8 degree | 4 degree (6 degree with<br>back anti-tip) |
| Travel distance SLA/Lithium | Up to 10/16.5km (Up to<br>6.2/10.2mile) | Up to 10/16km (Up to<br>6.2/10mile) | Up to 10/16.5km (Up to<br>6.2/10.2mile) |

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| | | Section 5 | | | |
|--------------------------------|----------------------------------------------------------------------|-----------------------|-----------------------|-----------------|--|
| | 510(k) Summary | | 5 / 9 | | |
| Battery charger SLA | 2A off board | 2A off board | | 2A off board | |
| Battery charger Lithium | 4A off board | 4A off board | | 4A off board | |
| Armrest height | 200mm (7.9") | 200mm (7.9") | | 200mm (7.9") | |
| Brake | Dynamic braking and | Dynamic braking and | Dynamic braking and | | |
| | electromagnetic brake | electromagnetic brake | electromagnetic brake | | |
| Controller | Dynamic LiNX LE | Dynamic LiNX LE | | Dynamic LiNX LE | |
| Brake distance-Normal | | | | | |
| operation | 1.0-1.5 m/s | 1.0-1.5 m/s | | 1.0-1.5 m/s | |
| (Horizontal-Forward-Max speed) | | | | | |
| Attendant joystick | Detachable joystick either mount on power chair or attendant control | | | | |
| (Optional) | handle. | | | | |

## 5.3 Equivalence comparison to marketed device

Technological characteristics :

Per the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], we choose C.T.M. Homecare Product, Inc. Power Chair Model HS-1500 (K073686) to be our primary predicate device The reasons are C.T.M. Homecare Product, Inc. Model HS-1500 had 510k already, similar intended use and technological characteristics to our subject devices.

The device features and use parameters of the C.T.M. Homecare Product, Inc. Power Chair Model HS-1500 (K073686) are very similar. Both are battery operated and have brake systems. Batteries capacity and battery chargers are similar and provided with the powered wheelchairs. Use parameters are very similar, varying only in minor parameters such as the grade climbable by the respective wheelchairs.

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Image /page/8/Picture/0 description: The image shows the word "SupaChair" in a stylized font. The letters are black and slightly slanted to the right. The "A" in "Supa" and the "A" in "Chair" are stylized to look like an upside-down "V".

| | EUROGREEN | C.T.M. Homecare | Differences | |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--|
| | International Inc. | Product, Inc. | | |
| K number | K173315 | K073686<br>Appendix 9.1 | | |
| Identification | Subject devices | Predicate device | | |
| Indication for Use | The device is a powered<br>wheelchair intended to<br>provide mobility to<br>persons restricted to a<br>sitting position. | The C.T.M. Power Chair<br>HS-1500 is an indoor /<br>outdoor powered<br>wheelchair that provides<br>transportation for a<br>disabled or elderly<br>person. | Similar | |
| Model Type | SAFARI/SAFARI<br>SPORT/MINI | HS-1500 | | |
| Drive wheel size | 200 mm (8"),<br>260 mm (10") | 200 mm (8") | Similar | |
| Caster wheel size | 100 mm (4"), 178 mm<br>( 7"), 200 mm (8") | 130 mm (5") | Similar | |
| Overall length | 850~910 mm (33.5~35.8") | 810 mm (31.9") | Similar | |
| Overall width | 550~610 mm (21.7~24") | 600 mm (23.6") | Similar | |
| Overall height | 800~865 mm (31.5~34") | 935 mm (36.8") | Lower due to no<br>headrest equipped. | |
| Standard seat width | 400~410 mm (15.8~16.2") | 470 mm (18.5") | Similar | |
| Standard seat depth | 380~400 mm (15~15.8") | | Similar | |
| Backrest height | 320~370 mm (12.6~14.6") | | | |
| Weight capacity | 150 kg<br>(330 lbs) | 115 kg (255 lbs) | These are options<br>according the<br>customer needs.<br>All models passed the<br>loading test.<br>(Appendix 7.4~7.6-1) | |
| Total weight with<br>batteries (SLA) | 37.7~40 kg<br>(83~88 lbs) | 47.8 kg (105.4 lbs) | It does not affect the<br>safety and<br>performance. | |
| Weight of motor<br>mount complete | 17.9~20.5 kg (39.4~45<br>llos) | | | |
| Heaviest piece | 17.9~20.5 kg (39.4~45<br>llos) | | | |
| Breaks down into | 2 pieces | | | |
| Weight of seat<br>(included armrest) | 9.4~10.6 kg (20.7~23.4<br>llos) | | It does not affect the<br>safety and<br>performance. | |
| Maximum speed SLA<br>battery | 5.2~9 kph (3.2~5.6 mph) | 6.3 kph (4 mph) | Similar | |
| Turning radius | 590~730 mm (23.2~28.7") | 695 mm (27.4") | Similar | |
| Ground clearance | 42~105 mm (1.6~4.1") | 40 mm (1.6") | Similar | |
| Battery<br>(SLA/Lithium) | 24V 15ah | 12V 14ah | It does not affect the<br>safety and<br>performance. | |
| Weight of battery<br>(SLA/Lithium) | 9.2 kq/4kq (20/9 lbs) | 10.4 kg (23 lbs) | It does not affect the<br>safety and<br>performance. | |
| Slope grade ability | 4~9 degree | 6 degree | Similar | |
| Travel distance<br>(SLA/Lithium) | Up to 10/16.5 km (Up to<br>6.2/10.2 mile) | 8.4 km (5.2 miles) | It does not affect the<br>safety and<br>performance. | |
| Battery charger SLA | 2A Off Board | 2A Off Board | It does not affect the<br>safety and<br>performance. | |
| Battery charger Lithium | 4A Off Board | | | |
| Armrest height | 200 mm (7.9") | | - | |
| Brake | Dynamic Braking and<br>Electromagnetic Brake | Electro- Mechanical | Similar | |
| Controller | Dynamic LiNX LE | | | |
| Brake distance-<br>Normal operation<br>(Horizontal-Forward-Max<br>speed) | 1.0-1.5 m/s | | It does not affect the<br>safety and<br>performance. (Ref.<br>Appendix 7.4~7.6-1) | |
| Attendant joystick<br>(Optional) | Detachable joystick either<br>mount on power chair or<br>attendant control handle. | | | |

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Image /page/9/Picture/5 description: The image shows the word "SupnChair" in a stylized font. The letters are all connected and in black. The "A" in "Supn" and the "A" in "Chair" are stylized to look like an upside down "V".

# Section 5 510(k) Summary

Page 7 / 9

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Image /page/10/Picture/0 description: The image shows the word "SupaChair" in a stylized font. The word is written in black and the letters are connected. The letters "A" in the word "Chair" are stylized to look like an upside down "V".

#### 5.4 Safety and Effectiveness

The substantially equivalence to other commercially products (powered wheelchair) including C.T.M. Homecare Product, Inc. Power Chair Model HS-1500 (K073686). The comparison table on above list the primary technical aspects and specifications that are pertinent to powered wheelchair. The "SupaChair" powered wheelchair is as safe and effective as the predicate devices.

#### 5.5 Non-clinical Testing

"SupaChair" powered wheelchair has done the series test to confirmation its safety and effectiveness in pre-clinical test. The tests are conducted with ISO 7176 serial standards. All test results are in compliance with it and were similar to predicate device.

- ISO 7176-1 : Static stability test
- ISO 7176-2 : Dynamic stability test ●
- ISO 7176-3 : Efficiency of brakes tests
- ISO 7176-4 : Theoretical distance range tests ●
- ISO 7176-5 : Overall dimensions, Mass, Turning, Diameter tests
- ISO 7176-6 : Maximum speed, acceleration and retardation tests
- ISO 7176-7 : Seating and wheel dimension tests
- ISO 7176-8 : Static, impact and fatigue strengths tests
- ISO 7176-9 : Climatic tests
- ISO 7176-10 : Obstacle-climbing ability tests ●

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Sup^Ch^iR

- ISO 7176-11 : Test dummies ●
- ISO 7176-13 : Determination of coefficient of friction of test surfaces
- ISO 7176-14 : Power and control system
- ISO 7176-15 : Information disclosure, documentation and labeling
- ISO 7176-21 (EN 12184) : EMC test
- ISO 7176-25 : Batteries and chargers for powered wheelchairs ●
- IEC 62133 : Secondary cells and batteries containing alkaline or other ● non-acid electrolytes-Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.

### 5.6 Conclusion

"SupaChair" powered wheelchair is a safe, reliable and effective medical device, meeting all declared requirements of its intended use and the device does not introduce new risks and does not present any adverse health effects or safety risks to patients when used as intended.