BRIO S19 power scooter is battery powered and configured with four solid wheels, a seat, a turning tiller column, a upper panel control, a main frame, a cross bar and an anti-tipper. BRIO S19 power scooter is operated by two rear wheels as the drive wheels and two front wheel as the steering wheel, using the upper panel control to control the turning tiller column mechanism to control the front wheel as the power scooter steering direction mechanism. Upper panel control is able to control driving forward, driving backward, speed control. The main frame is equipped with a rear bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. BRIO S19 power scooter maximum weight capacity is 220 lbs (100 kg), and BRIO S19 power scooter maximum speed is 5 mile/hr (8 km/hr).

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

Device: Heartway Power Mobility Scooter, BRIO S19
Predicate Device: Heartway Lightweight Power Mobility Scooter S34

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" as a separate, distinct list with numerical targets that the new device must meet independently for all parameters. Instead, the approach taken is a demonstration of substantial equivalence to a predicate device. The performance testing section lists the standards to which the device was tested, and the comparison tables highlight similarities and differences between the subject device (BRIO S19) and the predicate device (S34). The "acceptance criteria" are implied by the successful completion of these standards and the determination that any differences do not raise new questions of safety or effectiveness.

Therefore, the table below will combine the performance testing standards (which serve as the basis for acceptance) with the device characteristics and the conclusions drawn during the comparison.

Feature/Test	Acceptance Criteria (Implied by Standards Met/Predicate Equivalence)	Reported Device Performance (BRIO S19)
Intended Use	To provide mobility to persons restricted to a sitting position (same as predicate).	Intended for medical purposes to provide mobility to persons restricted to a sitting position.
Weight Limit	220 lbs (100 kg) (same as predicate).	220 lbs (100 kg).
Electronic Controller	Penny & Giles S-Drive (same as predicate).	Penny & Giles S-Drive.
Motor Type	3A 24V, 270W @1 (same as predicate).	3A 24V, 270W @1.
Battery Quantity/Type	Two, 12Ah / 12VDC (same as predicate).	Two, 12Ah / 12VDC.
Biocompatibility	Compliance with ISO 10993-1, -5 (predicate's standard) and ideally ISO 10993-10 (enhanced safety for subject device).	Patient contacting materials (Seat PVC, Hand grip PVC, Seat belt PVC) tested to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. FDA Form 3654 provided.
EMC (Electromagnetic Compatibility)	Compliance with ANSI / RESNA WC-2:2009 (Section 21) and relevant CISPR/IEC standards.	Passed EMC Test: ANSI / RESNA WC-2:2009 (Section 21), CISPR 11:2009, IEC61000-4-2: 2008, IEC61000-4-3: 2006+A1:2008+A2:2010, IEC61000-4-4:2004, IEC61000-4-5:2005, IEC61000-4-6:2008, IEC61000-4-8:2009, IEC61000-4-11:2004, and ISO 7176-21:2009.
Static Stability	Compliance with ISO 7176-1.	Passed ISO 7176-1:1999. (Specifically mentioned that safety on maximum inclined slopes was ensured.)
Dynamic Stability	Compliance with ISO 7176-2.	Passed ISO 7176-2:2001. (Specifically mentioned that safety on maximum inclined slopes was ensured.)
Braking Effectiveness	Compliance with ISO 7176-3.	Passed ISO 7176-3:2012.
Energy Consumption/Range	Compliance with ISO 7176-4, demonstrating practical range.	Passed ISO 7176-4:2008. Reported range: 18 km / 11.25 miles (longer than predicate's 10-15 km).
Dimensions/Maneuvering Space	Compliance with ISO 7176-5, ensuring appropriate physical characteristics.	Passed ISO 7176-5:2008. Overall dimensions: 930 mm L / 485 mm W / 945 mm H (smaller than predicate); Turning Radius: 820 mm (smaller than predicate).
Maximum Speed/Acceleration/Deceleration	Compliance with ISO 7176-6.	Passed ISO 7176-6:2001. Reported max speed: 8.0 km/hr (5.0 mile/hr) (larger than predicate's 7.8 km/hr).
Seating Dimensions	Compliance with ISO 7176-7.	Passed ISO 7176-7:1998. Seat dimensions: 395 mm W / 350 mm H (smaller than predicate).
Static, Impact, Fatigue Strength	Compliance with ISO 7176-8 (for manual wheelchairs, but applied to frame material).	Passed ISO 7176-8:1998 (implied for frame materials: aluminum alloy for subject, carbon steel for predicate; both passed strength and fatigue tests).
Climatic Tests	Compliance with ISO 7176-9.	Passed ISO 7176-9:2009.
Obstacle-Climbing Ability	Compliance with ISO 7176-10.	Passed ISO 7176-10:2008. Curb climbing ability: 45 mm / 1.7" (smaller than predicate's 50 mm). Note: The recommended "avoid going up multiple steps" and "too steep incline over 6 degrees" are operational limitations rather than acceptance criteria.
Test Dummies	Compliance with ISO 7176-11 (related to testing methodology).	Passed ISO 7176-11:2012.
Coefficient of Friction of Test Surfaces	Compliance with ISO 7176-13 (related to testing methodology).	Passed ISO 7176-13:1989.
Power and Control System	Compliance with ISO 7176-14.	Passed ISO 7176-14:2008. Electronic systems are the same as predicate and passed UL certifications.
Information Disclosure, Documentation, Labeling	Compliance with ISO 7176-15.	Passed ISO 7176-15:1996.
Resistance to Ignition of Upholstered Parts	Compliance with ISO 7176-16.	Passed ISO 7176-16:2012 (Back upholstery fabric).
Incline Capacity	Demonstrates safe operation on stated incline capacity as per ISO standards.	6 degrees (smaller than predicate's 10 degrees). Safety on the maximum inclined slope ensured by ISO 7176-1 and ISO 7176-2 tests.
Charger Safety	UL certification.	External (off-board) charger (4C24050A) with 24VDC output. Passed UL certification (UL E201162), similar to predicate's UL E241359.
Frame Material Strength	Strength and fatigue tests equivalent to predicate's carbon steel frame.	Aluminum alloy frame. Passed strength and fatigue tests (implied by the discussion stating "both carbon steel and aluminum alloy materials all passed the strength and fatigue tests").

2. Sample Size Used for the Test Set and the Data Provenance

This document describes premarket notification (510(k)) for a medical device. It relies heavily on performance testing conducted according to recognized international standards (ISO and ANSI/RESNA), along with a comparison to a predicate device.

Sample Size: The document does not specify the number of individual units (scooters) subjected to these performance tests. Typically, in compliance testing for medical devices, a representative sample (often one or a few units) is tested to demonstrate adherence to the standard's requirements, as the standards themselves dictate the testing procedures. It's not a study involving a large "test set" of patient data in the way an AI algorithm might be evaluated.
Data Provenance: The tests are performed by the manufacturer or accredited testing laboratories against international standards. The provenance is the manufacturer (Heartway Medical Products Co., Ltd., Taiwan) and the test reports generated by these compliance tests. This is a prospective assessment in the sense that the device was manufactured and then tested for compliance, rather than analyzing pre-existing patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of device submission (510(k) for a physical product like a mobility scooter, relying on engineering performance standards) does not typically involve "experts establishing ground truth for a test set" in the way an AI/software medical device does for clinical data. The "ground truth" here is adherence to the recognized engineering and safety standards (e.g., whether the brake effectively stops the scooter, whether the frame can withstand certain forces). This "ground truth" is established by the standard's specifications and the objective measurements of testing laboratories, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth for diagnostic AI, where there are subjective interpretations involved. The performance testing for this scooter involves objective measurements against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This is a physical medical device (mobility scooter), not an AI/software device that assists human readers/clinicians.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" is defined by the requirements and methodologies specified in the international performance standards (ISO 7176 series, ANSI/RESNA WC-2, CISPR, IEC). For example, the ground truth for "static stability" is defined by the test procedures and quantitative acceptance criteria within ISO 7176-1. The ground truth for "biocompatibility" is defined by the pass/fail criteria of the specified ISO 10993 tests.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The symbol is composed of three distinct shapes, each resembling a human head in profile, stacked on top of each other.

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

September 22, 2015

Heartway Medical Products Co., Ltd. Jen, Ke-Min Official Correspondent No.6 Road 25, Taichung Industrial Park, Taichung City, 40850 Taiwan

Re: K150987

Trade/Device Name: Heartway Power Mobility Scooter, BRIO S19 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 5. 2015 Received: August 19, 2015

Dear 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, 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 (reporting of medical device

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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/ResourcesforYou/Industry/default.htm. 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.

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,

Carlos L. Pena -SED/A

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) K150987

Device Name

Heartway Power Mobility Scooter, BRIO S19

Indications for Use (Describe)

The device is intended for medical purposes 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows a logo with a purple butterfly-like design set against a blue square. Below the square, the word "HEARTWAY" is written in bold, black letters. A thin, yellow line extends vertically from the left side of the image, ending in a small yellow circle.

Image /page/3/Picture/1 description: The image shows the contact information for Heartway Medical Products Co., LTD. The address is No. 6, Road 25, Taichung Industrial Park, Taichung, Taiwan R.O.C. 408. The telephone number is 886-4-23580357, and the fax number is 886-4-23590786. The website is www.heartway.com.tw, and the email address is sales@heartway.com.tw.

510(k) SUMMARY 5.

Submitter's Name:	HEARTWAY Medical Products Co., Ltd.No.6, Road 25, Taichung Industrial Park,Taichung, 40850, Taiwan, ROC
Date summary prepared:	August 9, 2015
Device Name:
Proprietary Name:	HEARTWAY Power Mobility Scooter, BRIO S19
Common or Usual Name:	POWERED SCOOTER
Classification Name	Motorized Three-Wheeled Vehicle, Class II,21 CFR 890.3800
Product Code:	INI
Company contact person:	Mr. Tien-hsing Yang (Email: yhead0722@hotmail.com)
Official Correspondent:	Dr. KE-MIN JEN (email: ceirs.jen@msa.hinet.net)TEL: 886-3-5208829, FAX: 886-3-5209783

Indications for Use:

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

Description of the device:

BRIO S19 power scooter is battery powered and configured with four solid wheels, a seat, a turning tiller column, a upper panel control, a main frame, a cross bar and an anti-tipper.

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Image /page/4/Picture/0 description: The image shows a logo with a purple flower-like design against a blue square. The flower has four petals and is positioned in the upper part of the square. A yellow line extends from the left side of the image, ending in a small circle. Below the square and line, the word "HEARTWAY" is written in bold, black letters.

EARTWAY MEDICAL PRODUCTS O

Image /page/4/Picture/2 description: The image contains two logos on a white background. The first logo is the "TUV CERT" logo, which features the letters "TUV" in a bold, sans-serif font above the word "CERT" in a smaller, sans-serif font, all enclosed within a circular border. Below this logo is a rectangular badge with rounded corners that reads "ISO-9001 CERTIFICATED" in a simple, sans-serif font. The text is arranged in two lines, with "ISO-9001" on the top line and "CERTIFICATED" on the bottom line.

BRIO S19 power scooter is operated by two rear wheels as the drive wheels and two front wheel as the steering wheel, using the upper panel control to control the turning tiller column mechanism to control the front wheel as the power scooter steering direction mechanism. Upper panel control is able to control driving forward, driving backward, speed control. The main frame is equipped with a rear bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. BRIO S19 power scooter maximum weight capacity is 220 lbs (100 kg), and BRIO S19 power scooter maximum speed is 5 mile/hr (8 km/hr).
The following surfaces are recommended not to operate on: ●
- Sand surface
- Wet or icy surface
- Road maintenance hole metal cover
- � Avoid going up multiple steps.
- Avoid using escalators. Use the elevator.
- Too steep incline over 6 degrees.
- Ground clearance to battery 60 mm / 2.3"
- Curb climbing ability 45 mm / 1.7"

Performance Testing:

(1) EMC Test: ANSI / RESNA WC-2:2009 (Section 21) Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods
- CISPR 11:2009
- IEC61000-4-2: 2008 ●
- IEC61000-4-3: 2006+A1:2008+A2:2010
- IEC61000-4-4:2004
- IEC61000-4-5:2005
- IEC61000-4-6:2008
- IEC61000-4-8:2009
- IEC61000-4-11:2004

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Image /page/5/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters. Above the word is a stylized butterfly shape in purple and white, set against a blue square. A thin yellow line extends from the left side of the butterfly shape down to the top of the word "HEARTWAY."

HEARTWAY MEDICAL PRODUCTS CO. NO 6 BOAD 25 TAICHUNG INDUSTRIAL I 886-4-23580357 (Sales) - 23583232 (Rep)

eb:www.heartway.com.tw
E-mail:sales@heartway.com.tw

ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999. (2)
ISO 7176-2 Wheelchairs Part 2: Determination of dynamic stability of electric (3) wheelchairs, 2001.
(4) ISO 7176-3 Wheelchairs - Part 3: Determination of effectiveness of brakes, 2012.
ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs (ર) for determination of theoretical distance range, 2008.
ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass (6) and manoeuvring space, 2008.
(7) ISO 7176-6 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, 2001.
ISO 7176-7 Wheelchairs Part 7: Determination of seating dimensions -(8) Definitions and measuring method, 1998.
(9) ISO 7176-8 Wheelchairs - Part 8: Static, impact and fatigue strength for manual wheelchairs. 1998.
(10) ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs, 2009.
ISO 7176-10 Wheelchairs Part 10: Determination of obstacle-climbing ability (11) of electrically powered wheelchairs, 2008.
(12) ISO 7176-11 Wheelchairs - Wheelchairs - Part 11: Test dummies, 2012.
(13) ISO 7176-13 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces. 1989.
(14) ISO 7176-14 : Power and control system for electric wheelchairs, 2008.
ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, (15) documentation and labelling, 1996.
(16) ISO 7176-16 Requirements and test methods for resistance to ignition of upholstered parts, 2012.
(17) ISO 7176-21 : Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009.

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Image /page/6/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 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. The image also includes the TÜV CERT and ISO-9001 CERTIFICATED logos.

Biocompatibility information

Patient contacting materials: Seat PVC material, Hand grip PVC material, Seat belt PVC material

We tested these patient contacting materials for compliance to the standards ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. We provide the FDA Form 3654 for these standards.

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Image /page/7/Picture/0 description: The image shows a logo with a butterfly design. The butterfly is purple and is set against a blue square. Below the butterfly is the word "HEARTWA" in bold, black letters. A yellow line extends from the left of the word "HEARTWA" and has a circle at the top.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

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 60

E-mail : sales@heartway.com.tw

CERTIFICATED

TÜV-

COMPARISON TABLE

Similarities

ITEMS	PREDICATE DEVICE	SUBJECT DEVICE	Safety andeffectiveness ofsubject devicecompared to thepredicate device
BRAND NAME	HEARTWAY	HEARTWAY	Same brand
MANUFACTURER	HEARTWAY Medical Products Co., Ltd.	HEARTWAY Medical Products Co., Ltd.	Same manufacturer
MODEL NO	S34	BRIO S19	Different model
510K NO	K101142	TBA	Different submission
SERIES	Lightweight PowerMobility Scooter Series	Power MobilityScooter series	Lighter scooterweight design
INTENDED USE	The device is intended formedical purposes toprovide mobility topersons restricted to asitting position.	The device is intended formedical purposes to providemobility to persons restrictedto a sitting position.	Same intended useand target population
Weight limit	100 kgs / 220 lbs	100 kgs / 220 lbs	Same weight
Electronicscontroller	Penny & GilesS-Drive	Penny & GilesS-Drive	Same controller
Motor	3A 24V, 270W @1	3A 24V, 270W @1	Same motor type
Footplates	ABS	ABS	Same footplatematerial

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Image /page/8/Picture/0 description: The image shows a logo for an organization called HEARTWAY. The logo features a purple butterfly-like shape against a blue square. The word HEARTWAY is written in bold, black letters below the square. A yellow line connects the left side of the word HEARTWAY to a yellow circle.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

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 പ

Image /page/8/Picture/3 description: The image shows the email address "sales@heartway.com.tw". The email address is preceded by the text "E-mail :". The text is in a sans-serif font and is black. The background is white.

Image /page/8/Picture/8 description: The image contains two logos. The first logo is the "TUV CERT" logo, which is a blue stamp with the words "TUV" on top and "CERT" on the bottom. The second logo is the "ISO-9001 CERTIFICATED" logo, which is a rounded rectangle with the words "ISO-9001" on top and "CERTIFICATED" on the bottom. Both logos are associated with quality and certification.

ಲ್ಲಿ

ITEMS	PREDICATE DEVICE	SUBJECT DEVICE	Safety andeffectiveness ofsubject devicecompared to thepredicate device
Suspension	Cross brace	Cross brace	Same
Back upholstery	Fabric	Fabric	Same
Wheel Lock	Push-to-Lock	Push-to-Lock	Same
Warranty	3 years: Main frame1 years: Controller / gear motor /batteries w/o exhaustive andwear parts	3 years: Main frame1 years: Controller / gear motor /batteries w/o exhaustive and wearparts	Same
Batteries
Quantity	Two	Two	Same battery
Type	12Ah /12VDC	12Ah /12VDC
Patient contactingmaterials	Seat PVC materialHand grip PVC materialSeat belt PVC material	Seat PVC materialHand grip PVC materialSeat belt PVC material	Same PVCmaterials
ITEMS	PREDICATE DEVICE	SUBJECT DEVICE	Safety andeffectiveness ofsubject device compared to thepredicate device
Overall dimensionOverall lengthOverall widthOverall height	995 mm / 39.0"490 mm / 19.3"940 mm / 37.0"	930 mm / 36.6"485 mm / 19.0"945 mm / 37.2"	Smaller dimensions
Armrest types	Flip-backward	No armrest	No armrest for subject device
Frame	Fixed / carbon steel	Fixed / Aluminum alloy	Lighter frame material
Seat dimensionSeat widthSeat height	570 mm / 22.5"408 mm / 16"	395 mm / 15.5"350 mm / 13.75"	Smaller dimensions
Rear wheels	8" x 3" solid x 2	8" x 2" solid x 2	Thinner tires
Front casters	8" x 3" solid x 2	7" x 1.6" solid x 2	Smaller tires
Turning Radius	950 mm / 37.4"	820 mm / 32.2"	Smaller radius
Ground clearance	70 mm / 2.8"	60 mm / 2.3"	Smaller clearance
Kerb climbingability	50 mm / 2.0"	45 mm / 1.7"	Smaller kerb
Scooter weight	w/ batteries 43.6kgs / 96 lbsw/o batteries 36.6kgs / 81 lbs	w/batteries 31.3kgs / 69 lbsw/o batteries 24.0kgs / 53 lbs	Smaller weight
Maximum speed	7.8 km/hr(4.875 mile/h )	8.0 km/hr(5.0 mile/h )	Larger speed
Incline	10 degrees	6 degrees	Smaller angle
Range per fullcharging	10~~15 km / 6~~9 miles	18 km / 11.25 miles	Longer cruise range

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Image /page/9/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters at the bottom. Above the text is a blue square with a stylized purple butterfly shape inside. To the left of the square, there is a yellow line with a small circle at the top, adding a design element to the logo.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

TÜV-GERT2

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 പ

E-mail : sales@heartway.com.tw

Differences:

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Image: HEARTWAY MEDICAL PRODUCTS CO.,LTD. logo and contact information
Battery Charger	External (off-board ) charger	External (off-board ) charger	Same type
Voltage output	24VDC (UL E241359 )	24VDC (UL E201162)	different modelswith samevoltage output
model	4C24020A	4C24050A
Biocompatibility	ISO 10993-1:2009ISO 10993-5:2009	ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2010	More testing

COMPARISON DISCUSSION

The intended uses and the target populations for the two devices are the same. The weight limit 100kgs / 220lbs, P&G S-Drive electronic controller, the type of motor and batteries, suspension of cross brace, footplates, warranty of the components, the back upholstery material, and patient-contacting materials are the same. The back upholstery fabric passed the resistance ignition test in accordance with ISO 7176-16.

The electronic systems for two devices are the same and passed the UL certifications. Though battery charger and the competent components are different, they all passed the UL certifications. Thus the same safety levels for the two devices are assured.

There is one more biocompatibility testing ISO 10993-10:2010 for the subject device than the predicate device. This can ensure more safety and biocompatibility for the users.

There is no armrest for the subject device since it is designed for lighter and faster ways. Armrest is not a safety factor for users. No armrest leads to less weight and more compact size for BRIO S19 and the safety and effectiveness concerns are also ensured.

The major differences between the subject device and the predicate device are scooter weights and dimensions, due to the subject device BRIO S19 using lighter mainframe material of aluminum alloy than the carbon steel material used by predicate device. But both carbon steel and aluminum alloy materials all passed the strength and fatigue tests. The safety and effectiveness concerns are ensured.

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Image /page/11/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, along with the company name in bold, black letters. The contact information includes 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).

We know work equals to force (= weight/9.8) times distance. The motor powers (=work/second) and the batteries are the same. So the subject device has larger cruise range per full charging than the predicate device since the subject device has lighter weight. In addition, it is also known that power equals to force times speed. For the same power, the force (weight/9.8) is inversely proportionally to the speed. So the subject device has larger maximum speed 8.0 km/hr (5.0mile/h) than the predicate device 7.8 km/hr (4.88 mile/hr) since BRIO S19 has lighter weight. In order to stand the larger scooter weight, the predicate device must have larger rear wheels and castors. For a larger rear wheels and castors of the predicate device, the turning radius is surely larger. This also leads to larger ground clearance and larger kerb climbing ability for the predicate device.

For a larger overall height and smaller seat height for the subject device, the center of weight with loaded user must be higher and the subject device must be less stable when moves on an incline. So: incline capabilities for subject device is 6° and for predicate device is 10°. But the safeties of both devices moving on the maximum inclined slopes were ensured by the ISO 7176-1 and ISO 7176-2 tests.

Despite of the above differences, the two devices all completed the performance tests in accordance with ISO 7176 series standards and the ANSI / RESNA WC 2, Section 21 for the EMC test. There are no safety and effectiveness aspects concerned. Thus, the two devices are substantially equivalent.

CONCLUSIONS

The subject device, HEARTWAY Power Mobility Scooter, BRIO S19, is as safe and effective as, and functions in a manner equivalent to the predicate device, HEARTWAY Lightweight Power Mobility Scooter S34. 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 device.

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).