Cutie Mini S16 is battery operated and configured with two rear pneumatic wheels as the drive wheels and two front pneumatic wheels as the steering wheels. The device uses the upper panel control to control the turning tiller column mechanism to control the front wheel as the steering directions. Upper panel control is able to control driving forward, driving backward, speed control and lighting function. The main frame is equipped with a rear bumper to allow the device to sustain an impact without damage to the power scooter safety system and with an independent suspension. Tuning tiller column is equipped with the head light, back mirrors, and a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward. Cutie Mini S16 maximum weight capacity is 300 lbs (135 kg), and the maximum speed is 3.6 mile/hr ( 6 km/hr). Owing to the feature of the body structure, the two rear wheels can always contact the surface, and the device can drive on the rough surface.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is a 510(k) premarket notification for a medical device (HEARTWAY Power Mobility Scooter, Cutie Mini S16). For devices like this, the "acceptance criteria" are generally demonstrating substantial equivalence to a predicate device by meeting recognized consensus standards for performance and safety. The document primarily focuses on comparing the new device to a predicate device (HEARTWAY Lightweight Power Mobility Scooter, S34) and showing that performance tests confirm its safety and effectiveness.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are usually aligned with international consensus standards for performance and safety. The reported device performance is indicated by its compliance with these standards and its specific design parameters.

Acceptance Criteria (Standard Compliance / Performance Parameter)	Reported Device Performance (Subject Device: Heartway Power Mobility Scooter, Cutie Mini S16)	Predicate Device Performance (Heartway Lightweight Power Mobility Scooter, S34)	Basis for Acceptance (Compliance to Standard / Comparison)
EMC Test: ANSI / RESNA WC-2:2009 (Section 21), CISPR 11:2009, IEC 61000 series	Compliant	Presumed Compliant (as predicate)	Certification of compliance to recognized standards.
Static Stability: ISO 7176-1:1999	Compliant	Compliant	Certification of compliance.
Dynamic Stability: ISO 7176-2:2001	Compliant	Compliant	Certification of compliance.
Brake Effectiveness: ISO 7176-3:2012	Compliant	Compliant	Certification of compliance.
Energy Consumption (Theoretical Range): ISO 7176-4:2008	Compliant (Range: 30 km / 19 miles)	Compliant (Range: 10-15 km / 6-9 miles)	Certification of compliance. Subject device has longer range, presenting no new safety issues.
Overall Dimensions, Mass, Maneuvering Space: ISO 7176-5:2008	Compliant (Larger dimensions, 83kg / 183lb w/ batteries, 1020mm / 40.1" turning radius)	Compliant (Smaller dimensions, 43.6kg / 96lb w/ batteries, 950mm / 37.4" turning radius)	Certification of compliance. Differences noted and addressed in comparison discussion (e.g., larger turning radius offset by lower max speed due to higher center of gravity).
Maximum Speed, Acceleration, Deceleration: ISO 7176-6:2001	Compliant (Max speed: 6.0 km/hr / 3.6 mile/hr)	Compliant (Max speed: 7.8 km/hr / 4.875 mile/hr)	Certification of compliance. Subject device's lower speed is a safety measure due to higher center of gravity.
Seating Dimensions: ISO 7176-7:1998	Compliant (Seat width: 570mm / 22.5", Seat height: 635mm / 25")	Compliant (Seat width: 570mm / 22.5", Seat height: 408mm / 16")	Certification of compliance. Higher seat height addressed in comparison discussion.
Static, Impact, Fatigue Strength: ISO 7176-8:1998	Compliant (Frame material: Aluminum Alloy pipe)	Compliant (Frame material: Carbon Steel Pipe)	Certification of compliance. Different materials passed same strength tests.
Climatic Tests: ISO 7176-9:2009	Compliant	Compliant	Certification of compliance.
Obstacle-Climbing Ability: ISO 7176-10:2008	Compliant (Ability: 60mm / 2.4")	Compliant (Ability: 50mm / 2.0")	Certification of compliance. Subject device has larger ability.
Test Dummies: ISO 7176-11:2012	Compliant	Compliant	Certification of compliance.
Coefficient of Friction of Test Surfaces: ISO 7176-13:1989	Compliant	Compliant	Certification of compliance.
Power and Control System: ISO 7176-14:2008	Compliant (Penny & Giles S-Drive 70A, UL E201162 certified recharger)	Compliant (Penny & Giles S-Drive 45A, UL E241359 certified recharger)	Certification of compliance. Same type of controller from same supplier, different volume, both UL certified.
Information Disclosure, Documentation, Labeling: ISO 7176-15:1996	Compliant	Compliant	Certification of compliance.
Resistance to Ignition of Upholstered Parts: ISO 7176-16:2012	Compliant (Back upholstery: Fabric)	Compliant (Back upholstery: Fabric)	Certification of compliance.
Electromagnetic Compatibility: ISO 7176-21:2009	Compliant	Compliant	Certification of compliance.
Biocompatibility (Patient Contacting Materials): ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010	Compliant (Seat PVC, Hand grip PVC, Seat belt PVC tested)	Compliant (ISO 10993-1:2009, ISO 10993-5:2009)	Certification of compliance. Subject device has "More testing" (ISO 10993-10:2010 adds irritation/skin sensitization).
Weight Limit: Max 135 kgs / 300 lbs	Meets (135 kgs / 300 lbs)	Lower (100 kgs / 220 lbs)	Demonstrated capability to support heavier users adequately.
Incline: Safer slope	6 degrees	10 degrees	Subject device offers a "Safer slope" capability (lower incline maximum reported as safer).

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

The document details compliance with various ISO and ANSI/RESNA standards for performance testing. These standards typically involve specific test setups and a limited number of test units (e.g., one or a few devices) for physical and electrical performance evaluations rather than large "sample sizes" in the statistical sense (like patients in a clinical trial). The tests described are laboratory-based performance tests for the device itself.

Sample Size: Not explicitly stated in terms of a "test set" sample size for statistical analysis (e.g., number of patients/cases). Instead, it refers to testing of the device(s) themselves. The implied sample size for each performance test is usually one or a few devices/components as per the specific test standard.
Data Provenance: The tests are standard-based performance tests, likely conducted in a controlled laboratory environment by the manufacturer or a certified testing facility. The document refers to "Performance Testing" without specifying the location. Based on the manufacturer's location (Taiwan), it is likely conducted there or by an internationally recognized testing body.
- Retrospective or Prospective: These are laboratory performance tests performed on the device model, not a retrospective or prospective study on users.

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

Not applicable. This is not a study involving expert assessment of images or clinical outcomes where a "ground truth" is established by human experts. The "ground truth" for these tests is defined by the objective measurement criteria and methodologies specified in the respective ISO and ANSI/RESNA standards. For example, static stability is measured by specific angles and forces, not by expert opinion.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described because there are no human-based assessments requiring reconciliation of opinions. The tests are objective measurements against defined 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 510(k) for a physical medical device (mobility scooter), not an AI/CAD (Computer-Aided Diagnosis) software. Therefore, no MRMC study or AI assistance is relevant.

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

Not applicable. This device is not an algorithm or software requiring standalone performance testing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is defined by the objective and measurable criteria set forth in the international consensus standards (ISO 7176 series, ANSI/RESNA WC-2, ISO 10993 series, etc.). For instance:

Static Stability: Ground truth is specific angles (e.g., 6 degrees incline) at which the device must remain stable.
Maximum Speed: Ground truth is the measurement of the device's actual maximum speed.
Biocompatibility: Ground truth is the results of specific chemical and biological tests (e.g., cytotoxicity, irritation) as per ISO 10993.

These are objective, quantitative measurements, not subjective expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train machine learning models. This document is about a physical device and its performance testing against engineering standards, not AI.

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

Not applicable, for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, representing health and human services.

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

September 29, 2015

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

Re: K150998 Trade/Device Name: HEARTWAY Power Mobility Scooter, Cutie Mini S16 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 13, 2015 Received: August 28, 2015

Dear Dr. Jen,

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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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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.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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,

Michael J. Hoffmann -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) K150998

Device Name

Heartway Power Mobility Scooter, Cutie Mini S16

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)

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)

hael J. Hoffmann

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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 the logo for Heartway. The logo features a purple butterfly-like design on top of a blue square. Below the square, the word "HEARTWAY" is written in bold, black letters. A thin, yellow line is also visible on the left side of the logo.

HEARTWAY MEDICAL PRODUC

5. 510(k) SUMMARY

Submitter's Name:	HEARTWAY Medical Products Co., Ltd.
	No.6, Road 25, Taichung Industrial Park,
	Taichung, 40850, Taiwan, ROC
Date summary prepared:	September 24, 2015
Device Name:	Proprietary Name: HEARTWAY Power Mobility Scooter, Cutie Mini S16
	Common or Usual Name: POWERED SCOOTER
Classification Name	Motorized Three-Wheeled Vehicle, Class II21 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
Predicate Device	HEARTWAY Lightweight Power Mobility Scooter, S34(K101142).

Indications for Use:

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

Description of the device:

Cutie Mini S16 is battery operated and configured with two rear pneumatic ● wheels as the drive wheels and two front pneumatic wheels as the steering wheels. The device uses the upper panel control to control the turning tiller

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Image /page/4/Picture/0 description: The image shows a logo with a purple butterfly-like shape inside a blue square. The word "HEARTWAY" is written in bold, black letters below the square. A thin yellow line connects a small yellow circle to the bottom left corner of the blue square, adding a subtle design element to the logo.

FARTWAY MEDICAL PRODUCTS C

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

CERT

ISO-9001
CERTIFICATED

column mechanism to control the front wheel as the steering directions. Upper panel control is able to control driving forward, driving backward, speed control and lighting function. The main frame is equipped with a rear bumper to allow the device to sustain an impact without damage to the power scooter safety system and with an independent suspension

Tuning tiller column is equipped with the head light, back mirrors, and a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward. Cutie Mini S16 maximum weight capacity is 300 lbs (135 kg), and the maximum speed is 3.6 mile/hr ( 6 km/hr)
Owing to the feature of the body structure, the two rear wheels can always contact the surface, and the device can drive on the rough surface. But the following surfaces are recommended not to operate on:
Sand surface
Wet or icy surface ●
Road maintenance hole metal cover
Too steep incline over 6 degrees.
Turning Radius: 1020 mm / 40.1"
Ground clearance 90 mm / 3.5''
Curb climbing ability: 60 mm / 2.4"

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 a stylized butterfly design above the word "HEARTWAY". The butterfly is purple and set against a blue square. To the left of the butterfly, there is a thin yellow line with a circle at the top. The word "HEARTWAY" is written in a bold, black font.

HEARTWAY MEDICAL PRODUC

Image /page/5/Picture/2 description: The image shows two logos on a white background. The first logo is the "TUV CERT" logo, which features the letters "TUV" in a stylized font above the word "CERT" enclosed in a double-lined oval. Below this, there's a rectangular box containing the text "ISO-9001 CERTIFICATED". The overall impression is that of a certification mark, possibly indicating compliance with ISO 9001 standards.

(2) ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999.
(3) ISO 7176-2 Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs, 2001.
(4) ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2012.
(5) ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs for determination of theoretical distance range, 2008.
(6) ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space, 2008.
(7) ISO 7176-6 Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, 2001.
(8) ISO 7176-7 Wheelchairs Part 7: Determination of seating dimensions 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.
(11) ISO 7176-10 Wheelchairs Part 10: Determination of obstacle-climbing ability 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.
(15) ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, 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.

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 provided Standard Data Report for 510(k) Forms (FDA Form 3654).

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Image /page/6/Picture/0 description: The image shows a logo with a purple butterfly-like shape on a blue square. Below the square, the word "HEARTWAX" is written in bold, black letters. A thin, yellow line extends from the left side of the word upwards, ending in a small 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 60

E-mail : sales@heartway.com.tw

Image /page/6/Picture/4 description: The image shows two logos. The first logo is the TUV CERT logo, which is a blue logo with the words "TUV CERT" in a stylized font. The second logo is the ISO-9001 CERTIFICATED logo, which is a blue logo with the words "ISO-9001 CERTIFICATED" in a simple font. The logos are placed on a white background.

COMPARISON TABLE

Similarities

ITEMS	PREDICATE DEVICE	SUBJECT DEVICE	Safety andeffectiveness ofsubject devicecompared to thepredicate device
BRAND NAME	HEARTWAY		Same brand
MANUFACTURER	HEARTWAY Medical Products Co., Ltd.		Same firm
MODEL NO	S34	Cutie Mini S16	Different model
510K NO	K101142	K150998	New listing withprior submissions
Proprietary name	Lightweight PowerMobility Scooter Series	Power MobilityScooter Series	Heavier weightdesign
Common or Usualname	Powered Scooter	Powered Scooter	Same name
Regulation Number	21 CFR 890.3800MotorizedThree-Wheeled Vehicle	21 CFR 890.3800MotorizedThree-WheeledVehicle	Same regulationnumber
Product Code	INI	INI	Same code
INTENDED USE	The device is intendedfor medical purposes toprovide mobility topersons restricted to asitting position.	The device isintended for medicalpurposes to providemobility to personsrestricted to a sittingposition.	Same intendeduses

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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 square, the word "HEARTWA" is written in black, with only part of the word visible.

HEARTWAY MEDICAL PRODUCTS CO .. LTD

ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN 86-4-23580357 (Sales) · 23583232 (Rep) FAX:886-4-23590786 ww.heartway.com.tw

Image /page/7/Picture/3 description: The image shows the email address sales@heartway.com.tw. The email address is written in a sans-serif font. The email address is likely associated with a business or organization.

Image /page/7/Picture/4 description: The image contains two logos related to quality certification. The top logo is the "TUV CERT" mark, which is a certification mark indicating that a product or service has been tested and certified by TUV, a reputable testing and certification organization. Below that is a rounded rectangle containing the text "ISO-9001 CERTIFICATED", indicating that the organization or product has been certified to meet the requirements of the ISO 9001 standard for quality management systems.

Same material Footplates ABS ABS Same Cross brace Suspension Cross brace Same Back upholstery Fabric Fabric Same Armrest types Flip-backward Flip-backward Same Wheel Lock Push-to-Lock Push-to-Lock Same Seat PVC material Seat PVC material Patient contacting Hand grip PVC material Hand grip PVC material material Safety belt PVC material Safety belt PVC material Same 3 years: Main frame 3 vears: Main frame Warranty 1 years: Controller / gear 1 years: Controller / motor / batteries w/o gear motor / batteries exhaustive and wear parts w/o exhaustive and wear parts

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Image /page/8/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters at the bottom. Above the text is a stylized purple butterfly shape against a blue square background. To the left of the logo is a thin yellow line with a small yellow 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 6.0

E-mail : sales@heartway.com.tw

TUV-CERTIFICATED P

Differences:

ITEMS	PREDICATE DEVICE	SUBJECT DEVICE	Safety and effectiveness ofsubject device comparedto the predicate device
Frame
Type	Fixed	Fixed	Same type
Material	Carbon Steel Pipe	Aluminum Alloy pipe	Lighter material
Dimensions
Overall length	995 mm / 39.0"	1195 mm / 47.0"	Larger
Overall width	490 mm /19.3"	620 mm / 24.4"	dimensions
Overall height	940 mm / 37.0"	1200 mm / 47.2"
Seat dimension
Seat width	570 mm /22.5"	570 mm / 22.5"	Same width
Seat height	408 mm / 16"	635 mm / 25"	Larger height

Weight limit	100 kgs / 220 lbs	135 kgs / 300 lbs	Heavier user
Rear wheels	8" x 3" solid x 2	11" x 4" pneumatic x 2	Larger size &different type
Casters	8" x 3" solid x 2	11" x 4" pneumatic x 2	Larger size &different type
Turning Radius	950 mm / 37.4"	1020 mm / 40.1"	Larger radius
Groundclearance	70 mm / 2.8"	90 mm / 3.5"	Larger clearance
Kerb climbingability	50 mm / 2.0"	60 mm / 2.4"	Larger ability
Scooter Weight	w/ batteries 43.6kgs / 96 lbs	w/ batteries 83kgs / 183 lb	Heavier weight
	w/o batteries 36.6kgs / 81 lbs	w/o batteries 60kgs/132 lbs
Maximum speed	7.8 km/hr (4.875 mile/h )	6.0 km/hr (3.6 mile/h )	Smaller speed
Incline	10 degrees	6 degrees	Safer slope
Electronics	Penny & GilesS-Drive 45A	Penny & GilesS-Drive 70A	Same type withdifferent volumecontrollers

Recharger	24VDC(UL E241359 certified)4C24020A	24VDC(UL E201162 certified)4C24050A	Different models withUL certificates
Model
Motor	3A, 24V, 270W	6A, 24V, 400W	Larger power
Batteries

Quantity	Two	Two	Same quantity
Type	12Ah 12VDC	36Ah 12VDC	Larger capacity
Range per fullcharging	10~~15 km / 6~~9 miles	30 km / 19 miles	Longer range
Biocompatibility	ISO 10993-1:2009ISO 10993-5:2009	ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2010	More testing

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Image /page/9/Picture/0 description: The image shows a logo with a butterfly design. The butterfly is purple and has four petals. The butterfly is set against a blue square. Below the square is the word "HEARTWA" in black, bold letters. A yellow line extends from the left side of the word to a yellow circle.

RTWAY MEDICAL PRODUC

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

E-mail : sales@heartway.com.tw

COMPARISON DISCUSSION

The intended uses for two devices are the same. PG S-Drive electric controller, suspension of cross brace, footplates, armrest type, the warranty of the components are the same. The back upholstery material is also the same and passed the resistance ignition test in accordance with ISO 7176-16.

The electronic systems between two devices, for example, the same type of S-Drive with different volume electronic controller, batteries, recharger, and the competent components are from the same suppliers, which were all passed UL certifications. Thus, the same electric safety level for the two devices is assured.

There are safer incline capabilities 6° and 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.

Mainframes of two devices are fixed type, and frame materials of the two devices are different but they both passed the strength and fatigue tests. The safety and effectiveness are ensured. The weight limit of HEARTWAY Lightweight Power Mobility Scooter, S34 is 100 kgs / 220 lbs and the subject device HEARTWAY Power Mobility Scooter Cutie Mini S16 is 135 kgs / 300 lbs. In order to load a heavier user, the subject device must be equipped with larger seat height and larger castors and rear wheels. In order to have a longer cruise range, the

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Image /page/10/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. A yellow line connects a small yellow circle to the word HEARTWAY, which is written in bold, black letters.

ARTWAY MEDICAL PRODUC

Image /page/10/Picture/9 description: The image contains two logos on a white background. The first logo is the "TUV CERT" logo, which is a blue logo with the letters "TUV" on top of the word "CERT". The second logo is a rounded rectangle with the text "ISO-9001 CERTIFICATED" inside. The text is in a simple, sans-serif font.

motor power and the battery capability must be larger seat height can thus load a larger battery volume. The larger castors and rear wheels lead to larger turning radius, ground clearance, kerb climbing ability. Finally, larger seat height, larger castors and rear wheels, bigger battery add to a heavier weight of the power scooter. The pneumatic tires for the subject device can absorb more impact while driving than the solid tires for the predicate device, thus leading to more comfort. Under normal driving and maintenance conditions, pneumatic tires have the same safety and effectiveness concerns as the solid tires.

In a word, the subject device has a higher seat due to the above considerations and thus possessing a higher center of weight, which leads to less stable capabilities and more tip over hazard when moving fast. So, the maximum speed of the subject device is reduced to a safety level. It is 6.0 km/h (3.6 mile/h) for subject device and 7.8 km/h (4.875 mile/h) for predicate device. This limitation can bring more safety level and reduce tip over hazard. Thus, the main difference between two devices is the seat height dimension only. This main difference is equalized by limiting the maximum speed.

At last, two devices pass the performance tests in accordance with ISO 7176 series standards and the ANSI / RESNA WC-2, Section 21 for the EMC test. The overall performances of the two devices are substantially equivalent.

CONCLUSIONS

The subject device, HEARTWAY Power Mobility Scooter, Cutie Mini S16, 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).