(117 days)
The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.
The device is a power wheelchair.
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: COMBI 18/ COMBI 20/ COMBI 18SP/ COMBI 20SP
The provided text is a 510(k) premarket notification for a powered wheelchair, the "SupaChair." It outlines the device's technical specifications, intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not describe acceptance criteria, a study that proves the device meets those criteria, or the detailed aspects of a clinical study for an AI/ML powered device.
The information provided relates to a physical medical device (a powered wheelchair), not an AI/ML algorithm. Therefore, many of the requested elements (like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop) performance," "ground truth establishment," "training set sample size," etc.) are not applicable to the content of this document.
The document focuses on demonstrating substantial equivalence to an existing predicate device based on technical characteristics and non-clinical testing (ISO standards for powered wheelchairs), rather than performance metrics of an AI/ML algorithm against a defined ground truth.
Therefore, I cannot extract the requested information from the provided text as it is not present. The document focuses on mechanical, electrical, and physical performance of a wheelchair, not the analytical or clinical performance of a diagnostic AI.
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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: K173313
Trade/Device Name: "SupaChair" Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 mediation-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
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Indications for Use
510(k) Number (if known) K173313
Device Name
"SupaChair" Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
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/0 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 "A"s are shaped like triangles.
Date: Dec 18, 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 | COMBI 18/ COMBI 20/ COMBI 18SP/ COMBI 20SP |
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| Section 5 | Page | ||
|---|---|---|---|
| 510(k) Summary | 2 / 10 | ||
| Drive wheel size | 200mm (8")260mm (10") | ||
| Caster wheel size | 178mm (7")200mm (8") | ||
| Overall Length | 1180mm (46.5") | ||
| Overall Width | 580 | ||
| Overall Height | 1010mm (39.8") | ||
| Standard Seat Width | 450 | ||
| Standard Seat Depth | 450mm (17.7") | ||
| Backrest height | 470mm (18.5") | ||
| Weight capacity | 150kg (330 lbs) | ||
| Total weight withbatteries (SLA) | 37.3 | ||
| Weight of motormount complete | 14.9 | ||
| Heaviest Piece | 14.9 | ||
| Breaks down into | 6 pieces | ||
| Maximum speed SLAbattery | 6.5 | ||
| Turning Radius | 900 | ||
| Ground clearance | 83mm (3.3") | ||
| Battery (SLA/Lithium) | 24V-15ah | ||
| Weight of battery(SLA/Lithium) | 9.2/4 kg (20/9 lbs) | ||
| Slope grade ability | 8~9 degrees | ||
| Travel DistanceSLA/Lithium | Up to 10/16.5km (Up to 6.2/10.2 mile) | ||
| SUONCHAR | Section 5 | Page | |
| 510(k) Summary | 3 / 10 | ||
| Battery charger SLA | 2A Off board | ||
| Battery chargerLithium | 4 A Off board | ||
| Armrest height | 160 | ||
| Brake | Dynamic braking and electromagnetic brake | ||
| Brake distance-Normal | |||
| operation | 1.0~1.5 m/s | ||
| (Horizontal-Forward-Maxspeed) | Adjustable from software according to market demand. | ||
| Attendant joystick | Detachable joystick either mount on power chair or | ||
| (Optional) | handle bar. |
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Sup^Chair
Section 5
510(k) Summary
Page
| COMBI 18 | COMBI 20 | COMBI 18SP | COMBI 20SP | |
|---|---|---|---|---|
| Drive wheels size | 200mm (8") | 200mm (8") | 260mm (10") | 260mm (10") |
| Caster wheels size | 178mm (7") | 178mm (7") | 200mm (8") | 200mm (8") |
| Overall length | 1180mm (46.5") | 1180mm (46.5") | 1180mm (46.5") | 1180mm (46.5") |
| Overall width | 580mm (22.8") | 620mm (25.2") | 580mm (22.8") | 620mm (25.2") |
| Overall height | 1010mm (39.8") | 1010mm (39.8") | 1010mm (39.8") | 1010mm (39.8") |
| Standard seat width | 450mm (17.7") | 490mm (19.3") | 450mm (17.7") | 490mm (19.3") |
| Standard seat depth | 450mm (17.7") | 450mm (17.7") | 450mm (17.7") | 450mm (17.7") |
| Back rest height | 470mm (18.5") | 470mm (18.5") | 470mm (18.5") | 470mm (18.5") |
| Weight capacity | 150kg (330 lbs) | 150kg (330 lbs) | 150kg (330 lbs) | 150kg (330 lbs) |
| Total weight with batteries (SLA) | 37.3kg (82 lbs) | 37.7kg (83 lbs) | 39.7kg (87 lbs) | 39.8kg (87.5 lbs) |
| Weight of motor mountcomplete | 14.9kg (32.8 lbs) | 15kg (33 lbs) | 17.3kg (38 lbs) | 17.4kg (38.2 lbs) |
| Heaviest piece | 14.9kg (32.8 lbs) | 15kg (33 lbs) | 17.3kg (38 lbs) | 17.4kg (38.2 lbs) |
| Breaks down into | 6 pieces | 6 pieces | 6 pieces | 6 pieces |
| Maximum speed SLA battery | 6.5kph (4mph) | 6.5kph (4mph) | 9kph (5.6mph) | 9kph (5.6mph) |
| Turning radius | 900mm (35.4") | 1100mm (43.3") | 900mm (35.4") | 1100mm (43.3") |
| Ground clearance | 83mm (3.3") | 83mm (3.3") | 83mm (3.3") | 83mm (3.3") |
| Battery (SLA/Lithium) | 24V15ah | 24V15ah | 24V15ah | 24V15ah |
| Weight of battery (SLA/Lithium) | 9.2/4kg (20/9 lbs) | 9.2/4kg (20/9 lbs) | 9.2/4kg (20/9 lbs) | 9.2/4kg (20/9 lbs) |
| Slope grade ability | 9 degree | 9 degree | 8 degree | 8 degree |
| Travel distance SLA/Lithium | Up to 10/16.5km (Upto 6.2/10.2mile) | Up to 10/16.5km (Upto 6.2/10.2mile) | Up to 10/16.5km (Upto 6.2/10.2mile) | Up to 10/16.5km (Upto 6.2/10.2mile) |
| Battery charger SLA | 2A off board | 2A off board | 2A off board | 2A off board |
| Battery charger Lithium | 4A off board | 4A off board | 4A off board | 4A off board |
| Armrest height | 160-215mm(6.3-8.5") | 160-215mm(6.3-8.5") | 160-215mm(6.3-8.5") | 160-215mm(6.3-8.5") |
| Brake | Dynamic braking andelectromagneticbrake | Dynamic braking andelectromagneticbrake | Dynamic braking andelectromagneticbrake | Dynamic braking andelectromagneticbrake |
| Brake distance-Normal operation(Horizontal-Forward-Max speed)Adjustable from software according tomarket demand. | 1.0-1.5 m/s | 1.0-1.5 m/s | 1.0-1.5 m/s | 1.0-1.5 m/s |
| Attendant joystick (Optional) | Detachable joystick either mount on power chair or handle bar. |
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Section 5
510(k) Summary
5 / 10
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Image /page/8/Picture/0 description: The image shows the word "SupaChair" in a stylized font. The letters are all connected and have a sleek, modern look. The word is in black and the background is white.
5.3 Equivalence comparison to marketed device
Technological characteristics :
Per the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], we choose OTTO BOCK Healthcare, LP to be our predicate device. The reasons are OTTO BOCK Healthcare, LP had 510k already, similar intended use and technological characteristics to our subject devices.
The device features and use parameters of the OTTO BOCK Healthcare, LP, A-200 Powered Wheelchair (K052706) are very similar. Both are battery operated and have brake systems. Batteries capacity and battery chargers are similar and provided with the powered wheelchair. Use parameters are very similar, varying only in minor parameters such as the grade climbable by the respective wheelchairs.
| EUROGREENInternational Inc. | OTTO BOCK Healthcare,LP | Differences | |
|---|---|---|---|
| K number | K173313 | K052706 | |
| Identification | Subject devices | Predicate device | |
| Indication for Use | "The device is apowered wheelchairintended to providemobility to personsrestricted to a sittingposition." | Provide mobility topersons physicallychallenged and limitedto sitting positions. | Similar |
| Model Type | COMBI 18/ COMBI20/ COMBI 18SP/COMBI 20SP | A-200 | |
| Drive wheel size | 200 mm (8")260 mm (10") | Smaller wheel for lowerspeed and better outputfor torque. | |
| Caster wheel size | 178 mm ( 7 " )200 mm (8") | Not effect to output | |
| Overall Length | 1180 mm (46.5") | 1000 mm | Similar |
| Overall Width | 580 | 570 mm | Similar |
| Overall Height | 1010 mm (39.8") | Similar | |
| Standard Seat Width | 450 | 340~480 mm | Similar |
| Standard Seat Depth | 450 mm (17.7") | 340~500 mm | Similar |
| Back rest height | 470 mm (18.5") | 550/500/450 mm | Similar |
| Weight Capacity | 150 kg (330 lbs) | 100 kg | These are optionsaccording the customerneeds. All models passedthe loading test.(Appendix 7.3~7.6) |
| Total Weight WithBatteries (SLA) | 37.3 | 66 kg | It doesn't affect thesafety and performance. |
| Weight of Motormount complete | 14.9 | ||
| Heaviest Piece | 14.9 | ||
| Breaks Down Into | 6 pieces | ||
| Maximum Speed SLAbattery | 6.5 | 6 km/h | Similar |
| Turning Radius | 900 | 870 mm | Similar |
| Ground Clearance | 83 mm (3.3") | ||
| Battery (SLA/Lithium) | 24V 15ah | 28 Ah (C5) AGMbatteries | It doesn't affect thesafety. |
| Weight of battery(SLA/Lithium) | 9.2 kg/4kg (20/9 lbs) | It doesn't affect thesafety. | |
| Slope Grade Ability | 8~9 degree | 12% | Similar |
| Travel DistanceSLA/Lithium | Up to 10/16.5 km (Upto 6.2/10.2 mile) | 15 km | It doesn't affect thesafety and performance. |
| Battery Charger SLA | 2A Off Board | It doesn't affect thesafety and performance. | |
| Battery ChargerLithium | 4A Off Board | ||
| Armrest Height | 160 | 225~350 mm | Similar |
| Brake | Dynamic Braking andElectromagneticBrake | Similar | |
| Brake distance-Normal operation(Horizontal-Forward-Maxspeed)Adjustable from software accordingto market demand. | 1.0~1.5 m/s | It doesn't affect thesafety and performance.(Ref. Appendix 7.3~7.6) | |
| Attendant joystick(Optional) | Detachable joystickeither mount on powerchair or handle bar. |
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Image /page/9/Picture/0 description: The image shows the word "SupnChair" in a stylized font. The letters are black and the word is written in a single line. The "A" in "Chair" is stylized to look like a chair.
Section 5 510(k) Summary
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Image /page/10/Picture/0 description: The image shows the word "Supachair" in a stylized font. The letters are all lowercase except for the "C" and "R", which are uppercase. The "A"s are shaped like triangles without the horizontal line. The text is black and the background is white.
5.4 Safety and Effectiveness
The substantially equivalence to other commercially product (powered wheelchair) OTTO BOCK HEALTHCARE, LP, A-200 Powered Wheelchair (K052706). 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.
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Sup^Ch^iR
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 fatique strengths tests
- ISO 7176-9 : Climatic tests
- ISO 7176-10 : Obstacle-climbing ability tests ●
- 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.
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Sup^Chair
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.
§ 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).