(117 days)
No
The summary describes a standard power wheelchair with no mention of AI or ML capabilities. The performance studies focus on mechanical and electrical safety and performance, not algorithmic performance.
No
The device is described as a power wheelchair intended to provide mobility, which is an assistive device rather than a device designed to treat or cure a medical condition.
No
The device is described as a power wheelchair intended for mobility, not for diagnosing any medical condition.
No
The device description explicitly states it is a powered wheelchair, which is a hardware device with battery operation and brake systems. The performance studies also focus on hardware-related testing (stability, brakes, speed, etc.).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a sitting position. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair with features related to mobility (battery operated, brake systems). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The testing performed (ISO 7176, IEC 62133) is related to the safety and performance of a mobility device, not diagnostic accuracy.
N/A
Intended Use / Indications for Use
The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.
Product codes
ITI
Device Description
| 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 |
Drive wheel size: 200mm (8"), 260mm (10")
Caster wheel size: 100mm (4"), 178mm (7"), 200mm (8")
Overall Length: 850910mm (33.535.8")
Overall Width: 550610mm (21.724")
Overall Height: 800865mm (31.534")
Standard Seat Width: 400410mm (15.816.2")
Standard Seat Depth: 380400mm (1515.8")
Backrest height: 320370mm (12.614.6")
Weight capacity: 150kg (330 lbs)
Total weight with batteries (SLA): 37.740kg (8388 lbs)
Weight of motor mount complete: 17.920.5kg (39.445 lbs)
Heaviest Piece: 17.920.5kg (39.445 lbs)
Breaks down into: 2 pieces
Weight of seat (included armrest): 9.410.6kg (20.723.4 lbs)
Maximum speed SLA battery: 5.29kph (3.25.6mph)
Turning Radius: 590730mm (23.228.7")
Ground clearance: 42105mm (1.64.1")
Battery (SLA/Lithium): 24V 15ah
Weight of battery (SLA/Lithium): 9.2/4 kg (20/9 lbs)
Slope grade ability: 4~9 degrees
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 operation (Horizontal-Forward-Max speed): 1.0-1.5 m/s
Attendant joystick (Optional): Detachable joystick either mount on power chair or attendant control handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a sans-serif font. The word "Administration" is on a separate line below "U.S. Food & Drug".
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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, |
| Changhua County, Taiwan | |
| Phone | +886-4-8319633 |
| Fax | +886-4-8332226 |
| Contact Person | David Hsieh |
| Contact Title | General Manager |
| Contact E-mail | sales@lawia.com |
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 | |
| Overall Width | 550 | |
| Overall Height | 800 | |
| Standard Seat Width | 400 | |
| Standard Seat Depth | 380 | |
| Backrest height | 320 | |
| Weight capacity | 150kg (330 lbs) | |
| Total weight with batteries | ||
| (SLA) | 37.7 | |
| Weight of motor mount | ||
| complete | 17.9 | |
| Heaviest Piece | 17.9 | |
| Breaks down into | 2 pieces | |
| Weight of seat (included | ||
| armrest) | 9.4 | |
| Maximum speed SLA | ||
| battery | 5.2 | |
| Turning Radius | 590 | |
| Ground clearance | 42 | |
| Battery (SLA/Lithium) | 24V 15ah | |
| Weight of battery | ||
| (SLA/Lithium) | 9.2/4 kg (20/9 lbs) | |
| Slope grade ability | 4~9 degrees | |
| Supachair | Section 5 | Page |
| 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 | ||
| operation | ||
| (Horizontal-Forward-Max speed) | 1.0-1.5 m/s | |
| Attendant joystick | ||
| (Optional) | Detachable joystick either mount on power chair or attendant control handle. |
5
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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 | |||
| (SLA) | 37.7kg (83 lbs) | 40kg (88 lbs) | 39.1kg (86 lbs) |
| Weight of motor mount | |||
| 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 | |||
| armrest) | 10.6kg (23.4 lbs) | 10.6kg (23.4 lbs) | 9.4kg (20.7 lbs) |
| Maximum speed SLA | |||
| battery | 6.5kph (4mph) | 9kph (5.6mph) | 5.2kph (3.2mph) |
| Turning radius | 700mm (27.6") | 730mm (28.7") | 590(565)mm/23.2" |
| (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 | |||
| (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 |
| back anti-tip) | |||
| Travel distance SLA/Lithium | Up to 10/16.5km (Up to | ||
| 6.2/10.2mile) | Up to 10/16km (Up to | ||
| 6.2/10mile) | Up to 10/16.5km (Up to | ||
| 6.2/10.2mile) |
7
| 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 | ||
| Appendix 9.1 | ||||
| Identification | Subject devices | Predicate device | ||
| Indication for Use | The device is a powered | |||
| wheelchair intended to | ||||
| provide mobility to | ||||
| persons restricted to a | ||||
| sitting position. | The C.T.M. Power Chair | |||
| HS-1500 is an indoor / | ||||
| outdoor powered | ||||
| wheelchair that provides | ||||
| transportation for a | ||||
| disabled or elderly | ||||
| person. | Similar | |||
| Model Type | SAFARI/SAFARI | |||
| SPORT/MINI | HS-1500 | |||
| Drive wheel size | 200 mm (8"), | |||
| 260 mm (10") | 200 mm (8") | Similar | ||
| Caster wheel size | 100 mm (4"), 178 mm | |||
| ( 7"), 200 mm (8") | 130 mm (5") | Similar | ||
| Overall length | 850 | 810 mm (31.9") | Similar | |
| Overall width | 550 | 600 mm (23.6") | Similar | |
| Overall height | 800 | 935 mm (36.8") | Lower due to no | |
| headrest equipped. | ||||
| Standard seat width | 400 | 470 mm (18.5") | Similar | |
| Standard seat depth | 380 | Similar | ||
| Backrest height | 320 | |||
| Weight capacity | 150 kg | |||
| (330 lbs) | 115 kg (255 lbs) | These are options | ||
| according the | ||||
| customer needs. | ||||
| All models passed the | ||||
| loading test. | ||||
| (Appendix 7.4~7.6-1) | ||||
| Total weight with | ||||
| batteries (SLA) | 37.7~40 kg | |||
| (83~88 lbs) | 47.8 kg (105.4 lbs) | It does not affect the | ||
| safety and | ||||
| performance. | ||||
| Weight of motor | ||||
| mount complete | 17.9 | |||
| llos) | ||||
| Heaviest piece | 17.9 | |||
| llos) | ||||
| Breaks down into | 2 pieces | |||
| Weight of seat | ||||
| (included armrest) | 9.4 | |||
| llos) | It does not affect the | |||
| safety and | ||||
| performance. | ||||
| Maximum speed SLA | ||||
| battery | 5.2 | 6.3 kph (4 mph) | Similar | |
| Turning radius | 590 | 695 mm (27.4") | Similar | |
| Ground clearance | 42 | 40 mm (1.6") | Similar | |
| Battery | ||||
| (SLA/Lithium) | 24V 15ah | 12V 14ah | It does not affect the | |
| safety and | ||||
| performance. | ||||
| Weight of battery | ||||
| (SLA/Lithium) | 9.2 kq/4kq (20/9 lbs) | 10.4 kg (23 lbs) | It does not affect the | |
| safety and | ||||
| performance. | ||||
| Slope grade ability | 4~9 degree | 6 degree | Similar | |
| Travel distance | ||||
| (SLA/Lithium) | Up to 10/16.5 km (Up to | |||
| 6.2/10.2 mile) | 8.4 km (5.2 miles) | It does not affect the | ||
| safety and | ||||
| performance. | ||||
| Battery charger SLA | 2A Off Board | 2A Off Board | It does not affect the | |
| safety and | ||||
| performance. | ||||
| Battery charger Lithium | 4A Off Board | |||
| Armrest height | 200 mm (7.9") | - | ||
| Brake | Dynamic Braking and | |||
| Electromagnetic Brake | Electro- Mechanical | Similar | ||
| Controller | Dynamic LiNX LE | |||
| Brake distance- | ||||
| Normal operation | ||||
| (Horizontal-Forward-Max | ||||
| speed) | 1.0-1.5 m/s | It does not affect the | ||
| safety and | ||||
| performance. (Ref. | ||||
| Appendix 7.4~7.6-1) | ||||
| Attendant joystick | ||||
| (Optional) | Detachable joystick either | |||
| mount on power chair or | ||||
| 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 ●
11
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.