The HEARTWAY Power Mobility Scooter. S15 is an indoor / outdoor powered scooter that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the powered scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an external battery recharger.

AI/ML Overview

The provided documents describe a 510(k) premarket notification for the HEARTWAY Power Mobility Scooter, S15. This is a submission for substantial equivalence to a predicate device, not a study performing a clinical trial to establish acceptance criteria for a new medical device technology. As such, the information typically requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, types of ground truth for a clinical study) are not present in these documents.

Instead, the documents demonstrate substantial equivalence by comparing the proposed device (S15) to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, S12, K092650) based on performance testing to recognized standards and direct comparison of specifications.

Here's a breakdown of the relevant information from the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present explicit "acceptance criteria" in the sense of predefined thresholds for a study. Instead, it relies on demonstrating compliance with recognized performance standards and direct specification comparison to a predicate device. The performance is "reported" through the completion of tests against these standards and the assertion of "same" or minor, justifiable differences in specifications.

Performance Characteristic/Standard	Predicate Device (S12) Performance	Subject Device (S15) Performance	Equivalence Rationale/Comment
Intended Use	For medical purposes to provide mobility to persons restricted to a sitting position.	For medical purposes to provide mobility to persons restricted to a seated position.	Same
Frame	Folded	Folded	Same
Frame Material	Carbon Steel Pipe	Carbon Steel Pipe	Same
Overall Length	1400 mm / 55.1"	1400 mm / 55.1"	Same (Implied, as no difference noted in the comparison table)
Overall Width	700 mm / 27.5"	700 mm / 27.5"	Same (Implied, as no difference noted in the comparison table)
Overall Height	1360 mm / 53.5"	1360 mm / 53.5"	Same (Implied, as no difference noted in the comparison table)
Seat Width	620 mm / 24.5"	Same	Same
Seat Height	820 mm / 32.25"	Same	Same
Weight Limit	160 kgs / 352 lbs	Same	Same
Maximum Speed	9.6 km/h (6.0 mile/h)	Same	Same
Batteries (Quantity, Type, Range)	Two, 50 Ah 12VDC, 40km / 25 miles	Same	Same
Motor	24V DC, 700 W	Same	Same
Rear Wheels	13" x 3.5" solid x 2	Same	Same
Casters	13" x 5.0" solid x 2	Same	Same
Footplates	ABS	Same	Same
Suspension	Cross brace	Same	Same
Incline	10 degrees	Same	Same
Turning Radius	1,280 mm / 50.4"	Same	Same
Ground Clearance	75 mm / 2.9"	Same	Same
Kerb Climbing Ability	80 mm / 3.1"	Same	Same
Back Upholstery	Fabric	Same	Same (passed resistance ignition test ISO 7176-16)
Armrest Types	Flip-backward	Same	Same
Wheel Lock	Push-to-Lock	Same	Same
Warranty	3 years: Main frame; 1 year: Controller / gear motor / batteries (w/o exhaustive and wear parts)	Same	Same
Patient Contacting Materials	Seat PVC, Hand grip PVC, Seat belt PVC	Same	Same
Biocompatibility	ISO 10993-1, ISO 10993-5	Same	Same
Wheelchair Weight (with batteries)	132 kgs (291 lbs)	136 kgs (299 lbs)	Difference of 4 kgs (approx. 3.03%). Deemed not to significantly change the center of weight, thus maintaining safety and effectiveness.
Electronics Controller	RHINO DS112K Drive	RHINO DS120 Drive	Both controllers are TUV certified.
Recharger Model	24VDC 4C24080A (UL E201162 certified)	24VDC 4F24050 (UL E241359 certified)	Both rechargers are UL certified.
EMC Report	ANSI / RESNA WC/Vol.2: 2009, CISPR 11: 2004+A2:2006, EN61000-4-2: 2008, IEC61000-4-3: 2006, IEC61000-4-8: 2001 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with [...] ANSI / RESNA WC 2, Section 21 for the EMC test")	Both devices demonstrate compliance with relevant EMC standards.
Static Stability	ISO 7176-1: 1999	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant stability standards.
Dynamic Stability	ISO 7176-2: 2001	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant stability standards.
Brakes Effectiveness	ISO 7176-3: 2012	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant braking effectiveness standards.
Energy Consumption	ISO 7176-4: 2008	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant energy consumption standards.
Overall Dimensions, Mass, Manoeuvring Space	ISO 7176-5: 2008	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant dimensional standards.
Max Speed, Acceleration, Deceleration	ISO 7176-6: 2001	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant speed and acceleration standards.
Seating Dimensions	ISO 7176-7: 1998	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant seating dimension standards.
Static, Impact, Fatigue Strength	ISO 7176-8: 1998	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant strength standards.
Climatic Tests	ISO 7176-9: 2009	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant climatic test standards.
Obstacle-climbing Ability	ISO 7176-10: 2008	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant obstacle-climbing standards.
Test Dummies	ISO 7176-11: 2012	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant test dummy standards.
Coefficient of Friction	ISO 7176-13: 1989	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant friction standards.
Power and Control System	ISO 7176-14: 2008	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant power and control system standards.
Information Disclosure, Documentation, Labeling	ISO 7176-15: 1996	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant information standards.
Resistance to Ignition of Upholstered Parts	ISO 7176-16: 2012	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant ignition resistance standards.
Electromagnetic Compatibility	ISO 7176-21: 2009	(Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards")	Both devices demonstrate compliance with relevant EMC standards.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. This is a device comparison based on compliance with standards and specifications, not a clinical trial with a "test set" of patients or data. The testing mentioned refers to performance testing on the physical device itself.
Data Provenance: The documents do not specify the provenance (e.g., country of origin, retrospective/prospective) of any clinical data because none appears to have been collected for this 510(k) submission. The performance testing was conducted according to international standards (ISO, ANSI/RESNA, CISPR, EN, IEC).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts/Qualifications: Not applicable. Ground truth for clinical data is not a concept applied in this 510(k) submission for a power mobility scooter. The "ground truth" here is compliance with engineering and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable. This refers to consensus among human readers in a clinical study, which is not relevant to this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study/Effect Size: No. This type of study is relevant to AI-powered diagnostics or image analysis, not a power mobility scooter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: No. This is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is established by adherence to international and national standards for medical devices and wheelchairs, such as the ISO 7176 series ("Wheelchairs") and ANSI/RESNA WC/Vol.2: 2009 (Electrically powered wheelchairs, scooters), as well as certifications for components (TUV, UL). These standards define performance requirements and test methods.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2014

HEARTWAY Medical Products Co., Ltd. Dr. Jen, Ke-Min, Official Correspondent No.6, Road 25, Taichung Industrial Park Taichung City 40850 TAWIAN, R.O.C.

Re: K132855

Trade/Device Name: HEARTWAY Power Mobility Scooter, S15 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: July 25, 2014 Received: July 30, 2014

Dear Dr. Jen, Ke-Min:

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. Isting 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 (reporting of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132855

Device Name

HEARTWAY Power Mobility Scooter, S15

Indications for Use (Describe)

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

e: 2014.08.29 38 -04'00'

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Image /page/4/Picture/0 description: The image shows a logo with a purple butterfly-like shape against a blue square. To the left of the square is a thin yellow line with a circle at the top. Below the square and line, the word "HEARTWA" is written in bold, black letters.

Image /page/4/Picture/2 description: The image contains two logos. The first logo is the "TUV CERT" logo, which is a blue circle with the words "TUV" in bold blue letters at the top and the word "CERT" in smaller blue letters below it. The second logo is a rounded rectangle with the words "ISO-9001 CERTIFICATED" in blue letters. The logos appear to be certification marks, indicating that a product or organization has met certain standards.

66 510(k) SUMMARY "

K132855

Submitter's Name: HEARTWAY Medical Products Co., Ltd.

No.6, Road 25, Taichung Industrial Park, Taichung, 40850, Taiwan, ROC

Date summary prepared:	August 21, 2014
Device Name:
Proprietary Name:	HEARTWAY Power Mobility Scooter, S15
Common or Usual Name:	POWERED SCOOTER
Classification Name:	MOTORIZED 4-WHEELED VEHICLE, Class II,21 CFR 890.3800
Product Code:	INI
Company contact	Henry Wu (henry@heartway.com.tw)
Official Correspondent	Dr. Jen, Ke-Min
	Tel: +886-4-23580357 Fax: +886-3-5209783
	Email: ceirc.jen@msa.hinet.net

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Description of the device:

Performance Testing:

1. EMC Report ANSI / RESNA WC/Vol.2: 2009, CISPR 11: 2004+A2:2006, EN61000-4-2: 2008, IEC61000-4-3: 2006, IEC61000-4-8: 2001 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods).
1. ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999.

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Image /page/5/Picture/0 description: The image shows a logo with a purple butterfly-like shape against a blue square. The butterfly shape is abstract and consists of rounded petals. To the left of the butterfly, there is a thin yellow line with a small circle at the top. Below the butterfly and the line, the word "HEARTWA" is written in bold, black letters.

EARTWAY MEDICAL PRODUCTS

Image /page/5/Picture/2 description: The image contains two logos on a white background. The first logo is for "TUV CERT" and features the letters "TUV" stacked on top of the word "CERT" inside of a circular design. The second logo is a rounded rectangle that contains the text "ISO-9001 CERTIFICATED".

1. ISO 7176-2 Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs, 2001.
1. ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2012.
1. ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs for determination of theoretical distance range, 2008.
1. ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space, 2008.
1. ISO 7176-6 Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, 2001.
1. ISO 7176-7 Wheelchairs Part 7: Determination of seating dimensions Definitions and measuring method, 1998.
1. ISO 7176-8 Wheelchairs Part 8: Static, impact and fatigue strength for manual wheelchairs, 1998.
1. ISO 7176-9 Wheelchairs Part 9: Climatic tests for electric wheelchairs, 2009.
1. ISO 7176-10 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs, 2008.
1. ISO 7176-11 Wheelchairs Wheelchairs Part 11: Test dummies, 2012.
1. ISO 7176-13 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces, 1989.
1. ISO 7176-14 : Power and control system for electric wheelchairs, 2008.
1. ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, documentation and labelling, 1996.
1. ISO 7176-16 Requirements and test methods for resistance to ignition of upholstered parts, 2012.
1. ISO 7176-21 : Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009.

Device major components description

The maximum weight bearing capacity of the device is 160 kgs / 350 lbs.

The feature of the body structure, the rear two wheels can always contact the surface, and the vehicle can operate on the rough surface. We provide the components and assembling drawing in the User's Manual. But the following surfaces are recommended not to operate on:

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Image /page/6/Picture/0 description: The image is a company logo for Heartway Medical Products Co., LTD. The logo includes a purple butterfly-like design on the left side of the image. The company's address is listed as No. 6, Road 25, Taichung Industrial Park, Taichung, Taiwan R.O.C. 408, and their phone number is 886-4-23580357.

Sand surface ●
Wet or icy surface
Road maintenance hole metal cover
Too steep incline over 10 degrees.
Turning Radius 1,280 mm / 50.4"
Ground clearance 80 mm / 3.15"
Kerb climbing ability 75 mm / 2.9"

Legally marketed device for substantial equivalence comparison:

Predicate Device: HEARTWAY Power Mobility Scooter, S12 (K092650)

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Image /page/7/Picture/0 description: This image shows the logo and contact information for Heartway Medical Products Co., LTD. The logo includes a stylized butterfly shape in purple and blue, along with the company name in bold letters. The contact information includes the company's address at No.6, Road 25, Taichung Industrial Park, Taichung, Taiwan R.O.C. 408, as well as their phone number, fax number, website, and email address.

Comparison Table:

Comparisonitems	PREDICATEDEVICE	SUBJECTDEVICE	Safety andeffectiveness ofsubject devicecompared to thepredicate.
BRANDNAME	HEARTWAY		Same
MANUFACTURER	HEARTWAY Medical Products Co., Ltd.		Same
SERIES	Power Mobility Scooter Series		Same
MODEL NO	S12	S15	Same
510K NO	K092650	K132855	Same
INTENDEDUSE	The device is intendedfor medical purposes toprovide mobility topersons restricted to asitting position.		Same
Frame	Folded		Same
Framematerial	Carbon Steel Pipe		Same
Overalldimension
Overalllength	1400 mm / 55.1"		Same
Overallwidth	700 mm / 27.5"		Same
Overallheight	1360 mm / 53.5"		Same

Seat Width	620 mm / 24.5"	Same	Same
Seat Height	820 mm / 32.25"	Same	Same
Weightlimit	160 kgs / 352 lbs	Same	Same
Maximumspeed	9.6 km/h ( 6.0 mile/h )	Same	Same
BatteriesQuantityTypeRange percharge	Two50 Ah 12VDC40km / 25 miles	Same	Same
Motor	24V DC, 700 W	Same	Same
Rear wheels	13" x 3.5" solid x 2	Same	Same
Casters	13" x 5.0" solid x 2	Same	Same
Footplates	ABS	Same	Same
Suspension	Cross brace	Same	Same
Incline	10 degrees	Same	Same
TurningRadius	1,280 mm / 50.4"	Same	Same
Groundclearance	75 mm / 2.9"	Same	Same
Kerbclimbingability	80 mm / 3.1"	Same	Same
Backupholstery	Fabric	Same	Same
Armresttypes	Flip-backward	Same	Same
Wheel Lock	Push-to-Lock	Same	Same

Warranty	3 years: Main frame1 years: Controller / gearmotor / batteries w/oexhaustive and wearparts	Same	Same
Patientcontactingmaterials	1.Seat PVC material2.Hand grip PVC material3.Seat belt PVC material	Same	Same
Biocompatibility	ISO 10993-1ISO 10993-5	Same	Same
Differences:
ITEMS	PREDICATE DEVICE	SUBJECT DEVICE	Safety andeffectiveness ofsubject devicecompared to thepredicate.
WheelchairWeight	w/ batteries 132 kgs(2911bs)w/o batteries: 94 kgs (207 lbs) w/o batteries 98kgs (216 lbs)	w/ batteries 136kgs(299 lbs)	4 kgs difference isabout 3.03% ofthe predicateweight, not tochange the centerof weight much.
ElectronicsController	RHINODS112K Drive	RHINODS120 Drive	Both controllersare TUV certified.
Rechargermodel	24VDC4C24080A(UL E201162 certified)	24VDC4F24050(UL E241359 certified)	Bothrechargers are ULcertified.

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Image /page/8/Picture/0 description: The image shows a logo with a purple butterfly-like design on a blue square. Below the square, the word "HEARTWAY" is written in bold, dark blue letters. A thin yellow line extends from the left side of the image, adding a subtle design element.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

TÜV-GERTA

CERTIFICATED

NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 TEL:886-4-23580357 (Sales) · 23583232 (Rep) FAX:886-4-23590786 Web : www.heartway.com.tw al

Image /page/8/Picture/3 description: The image shows the email address "sales@heartway.com.tw". The email is preceded by the text "E-mail :".

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Image /page/9/Picture/0 description: The image shows a logo with a purple flower-like shape on a blue square. A yellow line connects the flower to the word "HEARTWA" in bold black letters. The logo appears to be for an organization or company with a focus on heart or well-being.

HEARTWAY MEDICAL PRODUCTS CO .. L

NO.6, ROAD 25, TAICHUNG INDUSTRIAL TEL: 886-4-23580357 (Sales) . 23583232 (Rep) FAX: 886-4-23590786 Web : www.heartway.com.tw

Image /page/9/Picture/3 description: The image shows the email address "sales@heartway.com.tw". The email is preceded by the text "E-mail :". The text is in a sans-serif font and is black. The background is white.

Summary for substantial equivalence comparison:

The intended use between the two devices is the same. Mainframes of two devices are folded. All materials of the two devices meet the strength and fatigue tests and they use the same material. The same size of wheels, the weight limit, cruising range, maximum speed, incline capabilities, suspension of cross brace, footplates, armrest type, the

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Image /page/10/Picture/0 description: The image shows the logo and contact information for HEARTWAY MEDICAL PRODUCTS CO., LTD. The logo includes a stylized butterfly design in purple and blue. The text provides the company's address, phone and fax numbers (886-4-23580357, 886-4-23590786), website (www.heartway.com.tw), and email address (sales@heartway.com.tw).

warranty of the components, and the relevant specifications for ground clearance and curb climbing ability are all the same. The back upholstery material is also the same fabric and passed the resistance ignition test in accordance with ISO 7176-16.

The main differences among the two devices are the different models of the electronics controller and battery rechargers. But they are all certified ones. Thus, these differences only lead to the different wheelchair weights. The differences of weight between two devices are so small, only 3.03% of the predicate wheelchair weight. The 3.03% of the different weight does not lead to the large change of the centers of weight. The centers of weight are almost at the same point, thus the safety and effectiveness aspects are the same.

Two devices also completed the performance tests in accordance with ISO 7176 series standards and the ANSI / RESNA WC 2, Section 21 for the EMC test. The two devices are substantially equivalent.

Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).