Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance testing focus on standard mobility scooter features and safety standards, with no mention of AI or ML.

Therapeutic

Yes
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position, which aligns with the definition of a therapeutic device designed to alleviate or improve a medical condition.

Diagnostic

No
The "Intended Use / Indications for Use" states that the device is "intended for medical purposes to provide mobility to persons restricted to a sitting position." This indicates it's a mobility aid, not a device for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical power scooter with various hardware components (wheels, seat, tiller, frame, etc.) and mentions performance testing related to physical characteristics and standards for wheelchairs and scooters. There is no indication that the device is solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "to provide mobility to persons restricted to a sitting position." This is a physical function, not a diagnostic one.
Device Description: The description details a power scooter with components related to mobility (wheels, seat, tiller, controls). There is no mention of analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of that.
Performance Studies: The performance studies listed are related to the physical and electrical safety and functionality of a mobility device (stability, braking, speed, dimensions, etc.), not diagnostic accuracy or analytical performance.

Therefore, the Cutie S17 power scooter is a mobility aid, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

INI

Device Description

Cutie S17 power scooter is battery powered and configured with four pneumatic wheels, a swivel seat, a turning tiller column, an upper panel control, a main frame, a rear bumper, a front bumper, and an anti-tipper.
S17 power scooter is operated by two pneumatic rear wheels as the drive wheels and two pneumatic front wheels as the steering wheels, 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 and lighting function. The main frame is equipped with a rear bumper and a front bumper to allow the scooter to sustain an impact without damage to the power scooter safety system.
Turning tiller column is equipped with the head light, back mirrors, a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward. S17 power scooter maximum weight capacity: 300 lbs (135 kgs), S17 power scooter maximum speed: 3.6 mph (5.8 kph), and main frame is equipped with independent suspension. 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 10 degrees.
Ground clearance to battery: 3.73"/100 mm
Curb climbing ability: 3.73"/100 mm

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The subject devices pass the performance tests according to Safety standards of ISO 7176 series and the EMC test of ANSI / RESNA WC-2, Section 21:2009. The overall performances of the subject devices are ensured.

Key Metrics

Not Found

Predicate Device(s)

K101142

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

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

November 25, 2015

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

Re: K151656

Trade/Device Name: HEARTWAY Power Mobility Scooter, Cutie S17 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: October 19, 2015 Received: October 28, 2015

Dear Dr. Ke-Min 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

1

Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you 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,

William J. Heetderks -S

for

Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K151656

Device Name

Heartway Power Mobility Scooter, Cutie S17

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)

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."

3

Image /page/3/Picture/0 description: The image is a business card for Heartway Medical Products Co., LTD. The card includes the company's logo, which features a stylized butterfly in purple and blue. The card also lists the company's address, phone number, fax number, website, and email address. The card also includes the TÜV CERT and ISO-9001 CERTIFICATED logos.

5. 510(k) SUMMARY of the Safety and Effectiveness

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

No.6, Road 25, Taichung Industrial Park,

Taichung, 40850, Taiwan, ROC

Date summary prepared: November 24, 2015

510(k) Number: K151656

Proprietary Name: HEARTWAY Power Mobility Scooter, Cutie S17

Common or Usual Name: POWERED SCOOTER

Classification Name Motorized three-wheeled vehicle

(21 CFR 890.3800, Class II, )

Product Code: INI

Mr. TIEN-HSING YANG (Email: yhead0722@hotmail.com) Company contact person:

Official Correspondent: Dr. KE-MIN JEN (email: ceirs.jen@msa.hinet.net)

TEL: 886-3-5208829, FAX: 886-3-5209783

Predicate Device: HEARTWAY Medical Products Co., Ltd.

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.

4

Image /page/4/Picture/0 description: The image shows the logo and contact information for Heartway Medical Products Co., LTD. The logo features a stylized butterfly design in purple and blue. The text includes the company name, address, phone numbers (including sales and fax), website, and email address. Certifications from TUV and ISO-9001 are also displayed.

Description of the device:

Cutie S17 power scooter is battery powered and configured with four pneumatic wheels, a swivel seat, a turning tiller column, an upper panel control, a main frame, a rear bumper, a front bumper, and an anti-tipper.

S17 power scooter is operated by two pneumatic rear wheels as the drive wheels and two pneumatic front wheels as the steering wheels, 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 and lighting function. The main frame is equipped with a rear bumper and a front bumper to allow the scooter to sustain an impact without damage to the power scooter safety system.

Turning tiller column is equipped with the head light, back mirrors, a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward. S17 power scooter maximum weight capacity: 300 lbs (135 kgs), S17 power scooter maximum speed: 3.6 mph (5.8 kph), and main frame is equipped with independent suspension. 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 10 degrees.
Ground clearance to battery: 3.73"/100 mm
Curb climbing ability: 3.73"/100 mm

5

Image /page/5/Picture/0 description: This 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 company name. Below the company name is the company's address, phone number, fax number, website, and email address. On the right side of the logo are the TUV CERT and ISO-9001 CERTIFICATED logos.

Performance Testing:

(1) ANSI/ RESNA WC-2, Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters, 2009. (Exclusion of sections 4.2.3.1, 4.2.4, 4.2.5)
ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999. (2) (Exclusion of sections 9.4, 9.5, 10.4, 10.5, 11, 12.2)
ISO 7176-2 Wheelchairs Part 2: Determination of dynamic stability of electric (3) wheelchairs, 2001. (Exclusion of sections 8.5, 8.6, 9.3, 9.4, 9.5, 10.3, 10.4, 10.5)
ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, (4) 2012. (Exclusion of sections 7.3, 7.4, 7.5)
ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs (5) for determination of theoretical distance range, 2008.
ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass (6) and maneuvering space, 2008.
ISO 7176-6 Wheelchairs Part 6: Determination of maximum speed, (7) 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.
(11) ISO 7176-10 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs, 2008.

6

Image /page/6/Picture/0 description: This image shows the logo for Heartway Medical Products Co., LTD. The logo includes a purple butterfly design on the left side of the image. To the right of the butterfly is the company name and contact information, including the address, phone number, website, and email address. The image also includes the TÜV CERT and ISO-9001 CERTIFICATED logos.

(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.

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/7/Picture/0 description: The image shows a logo with a purple flower-like shape on a blue square. The flower has four petals and is positioned above the word "HEARTWAX" in bold, black letters. A thin, yellow line extends from the left side of the word upwards, ending in a small 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

TÜV-ISO-9001

CERTIFICATED P

COMPARISON TABLE

Similarities

| Comparison
items | Predicate device | Subject device | Safety and effectiveness
of subject device
compared to the
predicate device |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Manufacturer | HEARTWAY Medical Products Co., Ltd. | | Same manufacturer |
| Proprietary name | Lightweight Power
Mobility Scooter Series | Power Mobility
Scooter Series | Heavier weight design |
| Model | S34 | Cutie S17 | Different models |
| 510K Number | K101142 | K151656 | New listing |
| Common or
Usual name | Powered Scooter | Powered Scooter | Same common name |
| Intended use | The device is intended
for medical purposes to
provide mobility to
persons restricted to a
sitting position. | The device is intended
for medical purposes to
provide mobility to
persons restricted to a
sitting position. | Same intended use |
| Footplates | ABS | ABS | Same material |
| Incline | 10 degrees | 10 degrees | Same incline angle |
| Back upholstery | Fabric | Fabric | Same upholstery |
| Armrest types | Flip-backward | Flip-backward | Same armrest |
| Wheel Lock | Push-to-Lock | Push-to-Lock | Same wheel lock |
| Patient
contacting
material | Seat PVC material
Hand grip PVC material
Safety belt PVC material | Seat PVC material
Hand grip PVC material
Safety belt PVC
material | Same material |
| Biocompatibility | ISO 10993-1:2009
ISO 10993-5:2009
ISO 10993-10:2009 | ISO 10993-1:2009
ISO 10993-5:2009
ISO 10993-10:2010 | Same biocompatibility
evaluation |
| Comparison
items | Predicate device | Subject device | Safety and effectiveness
of subject device
compared to the
predicate device |
| Electronic
controller | Penny & Giles
S-Drive | Dynamic Rhino2
120 Amp | Different controllers |
| Frame
Type
Material | Fixed
Carbon Steel Pipe | Fixed
Aluminum Alloy pipe | Same type
Different material |
| Dimensions
Overall length
Overall width
Overall height | 39.0" (995 mm )
19.3" (490 mm)
37.0" (940 mm) | 51.9" (1320mm)
26.3" (670mm )
45.6" (1160mm) | Larger dimensions |
| Seat dimension
Seat width
Seat height | 22.5" (570 mm)
16" (408 mm) | 18.1" (460 mm)
18.1" (460 mm) | Smaller width
Larger height |
| Weight limit | 220 lbs (100 kgs) | 300 lbs (135 kgs) | Heavier user |
| Suspension | Cross brace | Full | |
| Rear wheels | 8" x 3"
solid type x 2 | 11" x 4"
pneumatic type x 2 | Larger size &
different type |
| Front Casters | 8" x 3"
solid x 2 | 11"x3.5"
pneumatic x2 | Larger size &
different type |
| Turning Radius | 37.4" (950 mm ) | 40.1" (1020 mm ) | Larger turning radius |
| Ground
clearance | 2.8" (70 mm ) | 3.93" (100 mm) | Larger ground
clearance |
| Kerb climbing
ability | 2.0" (50 mm ) | 3.93" (100 mm) | Larger kerb climbing
ability |
| HEARTWAY | | | |
| Scooter weight | w/ batteries: 96 lbs
(43.6 kgs)

w/o batteries: 81 lbs
(36.6 kgs) | w/ batteries: 247 lbs
(110 kgs)

4C24020A | 24VDC
(E201162 certified)

8

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 background. The word "HEARTWAY" is written in bold, black letters below the square. A thin yellow line is also visible to the left of the logo.

HEARTWAY MEDICAL PRODUCTS CO.,LTD.

TUV-

CERTIFICATED

P

6

00

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 100

E-mail : sales@heartway.com.tw

Differences

9

Image /page/9/Picture/0 description: The image shows a logo with a purple flower-like design on a blue square. The flower has four petals and is centered on the square. Below the square, the word "HEARTWAY" is written in bold, black letters. The logo appears to be for a company or organization called Heartway.

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 100

Image /page/9/Picture/3 description: The image shows two logos. The first logo is the "TÜV CERT" logo, which is a blue circle with the letters "TÜV" inside. The second logo is the "ISO-9001 CERTIFICATED" logo, which is a blue rounded rectangle with the text "ISO-9001 CERTIFICATED" inside. The logos are both blue and white.

6

00

E-mail : sales@heartway.com.tw

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Image /page/10/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters. Above the word is a blue square with a stylized purple flower or butterfly shape inside. To the left of the word and square is a thin, vertical yellow line with a small yellow circle at the top.

Image /page/10/Picture/2 description: The image shows the words "COMPARISON DISCUSSION" in bold, uppercase letters. The words are underlined with a thick black line. The text is centered and takes up most of the image.

The intended uses for two devices are the same. Incline capability, footplates, armrest type, wheel lock and the biocompatibility evaluation are the same. The back upholstery material is also the same and passed the resistance ignition test in accordance with ISO 7176-16.

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 weight limit of HEARTWAY Lightweight Power Mobility Scooter, S34 is 220 lbs (100kgs) and the subject device HEARTWAY Power Mobility Scooter Cutie S17 is 300 lbs (135 kgs). In order to load a heavier user, the subject device must be equipped with larger seat height and larger front and rear wheels. In order to have a longer cruise range, the motor power and the battery capability must be larger. The larger seat height can thus load a larger battery volume. The larger front and rear wheels lead to larger turning radius, ground clearance, kerb climbing ability. Finally, larger seat height, larger front and rear wheels, bigger batteries add to a heavier weight of the power scooter. The pneumatic tires and independent full suspension for the subject device can absorb more impact than the solid tires and cross brace suspension 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 a heavier user load design and thus possesses a higher center of gravity, which leads to less stable capabilities and more tip over hazard when moving fast. So, the maximum speed of the subject device is limited to smaller value. It is 3.6 mph (5.8 kph) for subject device and 4.8 mph (7.8 kph) for predicate device. This limitation can bring more safety and reduce tip-over hazard. This higher seat difference is equalized by limiting the maximum speed.

The electronic controllers are different, but the subject device met the requirements of the software validation and passed the relevant performance tests of ISO 7176-14:2008. Thus, the subject device doesn't raise any safety and effectiveness concerns.

The chargers are different type. The charger for the subject device is UL-certified. Thus, the subject device doesn't raise any safety and effectiveness concerns.

11

The larger power capability of battery for the subject device leads to a larger travel range per full charged battery than the predicate device. This difference is related to the safety aspect, but brings more convenience.

The warranty periods are shorter. Even the periods are shorter, the users are required to follow the instructions for use in the owner's manual to drive the scooter. The differences in warranty periods may lead to more consuming money paid by the users, but not related to the safety and effectiveness aspects.

At last, subject devices pass the performance tests according to Safety standards of ISO 7176 series and the EMC test of ANSI / RESNA WC-2, Section 21:2009. The overall performances of the subject devices are ensured.

CONCLUSIONS

The subject device, HEARTWAY Power Mobility Scooter Cutie S17, 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 subject 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.