The Merits Yoga Power Scooter, S542, is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.

Device Description

The Merits Yoga Power Scooter, S542, is battery powered, rear transaxle driven and is controlled by the PG S-Drive 45amp controller. The user interface is a wig-wag control lever and a speed knob on the control panel. S542 is powered by one 12 VDC 11.5Ah battery. The batteries are charged by 4.3A off-board charger connect with 3-pin Microphone Connector to charging socket on the rear shroud. The approximate driving range on fully charged batteries is up to 18km (11.3mi). The scooter frame is a welded aluminum construction and includes 2 rear wheels with drive units (including motor, gear box, and brake), a removable battery pack, a front wheel set which consists of 2 wheels for better stability and a tiller to control its turning direction. When the user activates the wig-wag control lever, the controller receives a signal to release the brakes. With the brakes released, the scooter is allowed to move forwards or backwards. When the user releases the control lever, the scooter slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the control lever. The frame is designed to be foldable for easy storage and transportation.

For safety reason, this solenoid electromechanical brake is designed as normal close type. In case of the brake or electrical failure, the brake shoe will re-engage automatically to prevent the movement of the scooter. The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices.

The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

AI/ML Overview

This document is a 510(k) premarket notification for the Merits Yoga Power Scooter, S542. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and an independent study for the S542. Therefore, much of the requested information about device performance against acceptance criteria for an AI/CAD-type device is not applicable or cannot be extracted from this document, as this is a physical medical device.

However, I can extract information related to the performance testing done to show substantial equivalence.

Here's the breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a typical "acceptance criteria" table in the sense of a statistical performance target for a diagnostic device (e.g., sensitivity, specificity). Instead, it relies on demonstrating compliance with a series of ISO standards for mobility devices and comparing key characteristics to a predicate device. The "reported device performance" is essentially that the device passed these ISO tests and its characteristics are within an acceptable range or are superior to the predicate device without raising new safety concerns.

Characteristic / Test	Acceptance Criteria (Implied by ISO Standard Compliance & Predicate Comparison)	Reported Device Performance (Merits Yoga Power Scooter, S542)
Functional & Safety Standards	Compliance with relevant ISO 7176 series standards for wheelchairs and scooters, and ISO 14971 for risk management.	Passed:
	- ISO 7176-1:1999 Determination of Static Stability	- Device passed.
	- ISO 7176-2:2001 Determination of Dynamic Stability of electric wheelchairs	- Device passed. Addressed differences in Turning Radius, Dimension, and Max. Speed by confirming no deleterious effect.
	- ISO 7176-3:2012 Determination of effectiveness of brakes	- Device passed.
	- ISO 7176-4:2008 Energy consumption... determination of theoretical distance range	- Device passed. Travel range of 11.25 miles (better than predicate's 10 miles).
	- ISO 7176-5:2008 Determination of overall dimensions, mass and maneuvering space	- Device passed. Differences in dimensions accepted due to stability tests.
	- ISO 7176-6:2001 Determination of maximum speed, acceleration and deceleration	- Device passed. Max. Speed 4 mph (vs predicate's 4.5 mph), confirmed no deleterious effect.
	- ISO 7176-7:1998 Method of Measurement of Seating and Wheel Dimensions	- Device passed.
	- ISO 7176-8:1998 Requirements and test methods for static, impact and fatigue strengths	- Device passed. Addressed differences in Max. Speed, Weight, and Battery by confirming no deleterious effect.
	- ISO 7176-9:2009 Climatic tests for wheelchairs	- Device passed.
	- ISO 7176-10:2008 Determination of obstacle-climbing ability	- Device passed.
	- ISO 7176-11:2012 Test dummies	- Device passed.
	- ISO 7176-13:1989 Determination of coefficient of friction of test surfaces	- Device passed.
	- ISO 7176-14:2008 Power and control systems...	- Device passed.
	- ISO 7176-15:1996 Requirements for Information Disclosure, Documentation and Labeling	- Device passed.
	- ISO 7176-16:2012 Resistance to ignition of postural support devices	- Device passed. Upholstery complies.
	- ISO 7176-21:2009 Requirements and test methods for electromagnetic compatibility	- Device passed.
	- ISO 14971:2007 Medical devices -- Application of risk management	- Device passed.
Key Device Characteristics (Comparison to Predicate: Merits Travel Ease Electric Scooter, Model Pioneer 5)	Substantially equivalent or demonstrably safe/effective despite differences.
Max. Speed	No deleterious effect compared to predicate (4.5 mph).	4 mph (Passed ISO 7176-2 & ISO 7176-8 tests demonstrating no deleterious effect despite lower speed).
Range up to	No less than predicate (10 miles).	11.25 miles (Better than predicate).
Weight	No deleterious effect compared to predicate (92 lb total, 50 lb base).	56.7 lb total, 53 lb base (lighter, passed ISO 7176-8 confirming no deleterious effect; beneficial for transport).
Battery	Safe and effective compared to predicate (24V/12Ah Lead Acid Battery).	24V/11.5Ah Li-ion Battery (lighter, longer range; passed ISO 7176-8 and UN 38.3 Transportation Testing for safety, confirming no deleterious effect).
Turning Radius	No deleterious effect compared to predicate (33.8").	37.8" (Passed ISO 7176-2 tests confirming no deleterious effect).
Dimension (L, W, H)	No deleterious effect compared to predicate (L: 38.5", W: 19.7", H: 48").	L: 39"/20.2", W: 17.2", H: 39.6"/24.2" (Passed ISO 7176-1 & ISO 7176-2 tests confirming no deleterious effect).
Suspension	No deleterious effect compared to predicate (No Suspension).	Front Wheel Leaf Spring (More comfortable; passed ISO 7176-2 & ISO 7176-8 tests confirming no deleterious effect).

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

Sample Size: The document does not specify a "sample size" in terms of number of devices tested or cases, but implies that one or more Merits Yoga Power Scooters, S542, were subjected to the specified ISO standard tests. For physical device testing against standards, typically a representative sample is used, but a specific number is not provided.
Data Provenance: The tests were conducted to comply with international (ISO) standards. The manufacturer is Merits Health Products Co., Ltd. in Taiwan, which implies the testing likely occurred at accredited labs in Taiwan or through international certification bodies. The document does not explicitly state if the testing was retrospective or prospective, but standard compliance testing is typically performed prospectively as part of product development and validation.

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

This is not applicable to a physical mobility device like a scooter. "Ground truth" established by experts is typically relevant for diagnostic AI/CAD devices where clinical opinions or pathology results define the correct answer. For this product, the "ground truth" is defined by compliance with engineering standards and performance specifications.

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

This is not applicable. Adjudication methods are specific to expert review or consensus building for diagnostic interpretations, not for physical device performance testing against objective standards.

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

This is not applicable. MRMC studies are for evaluating diagnostic image interpretation by human readers, often with and without AI assistance. This document describes a physical mobility device.

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

This is not applicable. "Standalone performance" refers to the performance of an algorithm without human interaction, relevant for AI/CAD devices. This is a physical scooter.

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

The "ground truth" for this device is compliance with established international engineering and safety standards (ISO 7176 series, ISO 14971) and meeting stated performance specifications (e.g., speed, range, weight capacity). The benchmark for "substantial equivalence" is also the performance and characteristics of the identified predicate device (Merits Travel Ease Electric Scooter, Model Pioneer 5 – K013788).

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a physical mobility device. Training sets are relevant for machine learning algorithms.

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

This is not applicable for the same reason as above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

June 23, 2015

Merits Health Products Co., Ltd. Vincent Chen, Manager No.18 Jingke Rd. Nantun District Taichung, 40852 Taiwan R.O.C.

Re: K142912

Trade/Device Name: Merits Yoga Power Scooter, S542 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: May 26, 2015 Received: June 1, 2015

Dear Mr. Chen,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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.

Felipe Aquel -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) K142912

Device Name Merits Yoga Power Scooter, S542

Indications for Use (Describe)

The Merits Yoga Power Scooter, S542, is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.

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.

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}------------------------------------------------

510(k) SUMMARY

Merits Health Products Co., LTD. 510(k) Premarket Notification

Submitter:

Merits Health Products Co., LTD. No.18, Jingke Rd., Nantun Dist. Taichung City 40852, Taiwan (R.O.C.)

Contact Person:

Vincent Chen Merits Health Products Co., LTD. No.18, Jingke Rd., Nantun Dist., Taichung City 40852, Taiwan (R.O.C.) Phone: +886-4-23594985 ext.200 Fax: +886-4-23594992

Date Prepared:

Dec. 18, 2014

Proprietary Name:

Merits Yoga Power Scooter, S542

Common name:

Three Wheel Power Scooter

Classification name:

Physical Medicine / Motorized Three - Wheeled Vehicle

Product Code:

INI

Regulation number:

890.3800

Comparison to Predicate Devices:

This submission indicates the Substantial Equivalence of the Merits Yoga Power Scooter, S542, with the predicate Travel Ease Electric Scooter, Model Pioneer 5 (K013788). S542 has the same intended uses and similar indications, technological characteristics and principles of operation with predicate device.

{4}------------------------------------------------

Device Description

The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

The Merits Yoga Power Scooter. S542, is substantially equivalent to the Merits Travel Ease Electric Scooter, Model Pioneer 5 (K013788). Both products are battery power, motorized vehicles designed for use as personal power mobility aids. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered vehicle. Additional, they are all constructed from the same basic materials, have the same basic operational principles and all use DC batteries as their source of power.

Although there are some minor differences between S542 and its predicate device. But they raise no new issues of safety or effectiveness. Performance data demonstrate that S542 is safe. The non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.

Intended Use

The Merits Yoga Power Scooter, S542, is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.

{5}------------------------------------------------

Discussion of Non-clinical Tests Performed for Determinations of Substantial equivalence are as follows:

ISO 7176-1:1999 Determination of Static Stability
ISO 7176-2:2001 Determination of Dynamic Stability of electric wheelchairs
ISO 7176-3:2012 Determination of effectiveness of brakes
Energy consumption of electric wheelchairs and scooters for ISO 7176-4:2008 determination of theoretical distance range
Determination of overall dimensions, mass and maneuvering ISO 7176-5:2008 space
Determination of maximum speed, acceleration and ISO 7176-6:2001 deceleration of electric wheelchairs
ISO 7176-7:1998 Method of Measurement of Seating and Wheel Dimensions
Requirements and test methods for static, impact and fatigue ISO 7176-8:1998 strengths
ISO 7176-9:2009 Climatic tests for wheelchairs
Determination of obstacle-climbing ability of electrically power ISO 7176-10:2008 wheelchairs
ISO 7176-11:2012 Test dummies
ISO 7176-13:1989 Determination of coefficient of friction of test surfaces
Power and control systems for electrically powered ISO 7176-14:2008 wheelchairs and scooter- Requirements and test methods.
Requirements for Information Disclosure, Documentation and ISO 7176-15:1996 Labeling
ISO 7176-16:2012 Resistance to ignition of postural support devices
requirements and test methods for electromagnetic ISO 7176-21:2009 compatibility of electrically powered wheelchairs and scooters, and battery chargers.
Medical devices -- Application of risk management to medical ISO 14971:2007 devices

The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

{6}------------------------------------------------

Substantial Equivalence Discussion

The Merits S542 Scooter is substantially equivalent to the Merits Travel Ease Electric Scooter, Model Pioneer 5 (K013788). Both products are battery power, motorized, seating systems designed for use with electric scooters. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls. Additional, they are all constructed from the same basic materials, have the same basic operational principles and all use DC batteries as their source of power. The comparison table is as follow:

Characteristics		Merits Yoga Power Scooter,S542	Merits Travel Ease ElectricScooter, Model Pioneer 5
Intended Use		To provide mobility to adultpersons limited to a sittingposition and capable to operatea few simple controls.	To provide mobility to adultpersons limited to a sittingposition and capable to operatea few simple controls.
Dimension	Length	39" (±0.6") / 20.2" (±0.6")	38.5"
	Width	17.2" (±0.6")	19.7"
	Height	39.6" (±0.6") / 24.2" (±0.6")	48"
Weight	Total	56.7 lb	92 lb
	Base	53 lb (Seat Not Removable)	50 lb
	Seat		19 lb
	Battery	3.7lb	23lb
Seat Height (FromDeck)		15.6"	16"
Seat Width		14.2"	14"
Seat Depth		12.4"	12.5"
Armrest Type		Removable & Flip Backward	Removable & Flip Backward
Weight Capacity		250 lb	250 lb
Gradient		6°	6°
Turning Radius		37.8"	33.8"
Ground Clearance		3.7"	2.4"
Tires		Front: 6"/ Rear: 7" (PU Tires)	Front: 8"/ Rear: 8" (PU Tires)
Suspension		Front Wheel Leaf Spring	No Suspension
Max. Speed		4 mph	4.5 mph
Range up to		11.25 miles	10 miles
Power		24V/11.5Ah Li-ion Battery	24V/12Ah Lead Acid Battery

There are some difference between S542 and its predicate device raise:

a. Turning Radius: The device passed ISO 7176-2:2001(Determination of Dynamic Stability of electric wheelchairs): Item 10.3 and 10.4. So there is no deleterious affection of safety and effectiveness about the difference on Turning Radius with predicated device.
b. Dimension: The device passed ISO 7176-1:1999 (Determination of Static Stability) and ISO 7176-2:2001(Determination of Dynamic Stability of electric wheelchairs). So there is no deleterious affection of safety and effectiveness about the difference on Dimension with predicated device.
c. Range up to: The travel range of S542 is better than the predicated device.
d. Max. Speed: The device has passed ISO 7176-2:2001(Determination of Dynamic Stability of electric wheelchairs) & ISO 7176-8 (Requirements and test methods for static, impact and fatigue strengths) test (Please see Appendix IV: Test reports). So there is no deleterious affection of safety and

{7}------------------------------------------------

effectiveness about the difference on Max. Speed with predicated device.

e. Weight: Although the total weight of S542 is lighter than Merits Travel Ease Electric Scooter, Model Pioneer 5 (K013788). The device has passed ISO 7176-8 (Requirements and test methods for static, impact and fatigue strengths) test (Please see Appendix IV: Test reports). So there is no deleterious affection of safety and effectiveness about the difference on Weight with predicated device. As the S542 is lighter than the predicate device, it is more suitable for user to carry and transport by vehicles.
f. Battery: The S542 is using Li-ion Battery. It is lighter than the conventional Lead Acid Batteries. Although the capacity of the new battery is slightly smaller than the predicated device. Its travel rang is longer than the predicated device. The device has passed ISO 7176-8 (Requirements and test methods for static, impact and fatigue strengths) test (Please see Appendix IV: Test reports). And the Li-ion Battery has passed the UN 38.3 Transportation Testing Required for Lithium Battery Safety during Shipping to ensure its safety. (Please see Appendix X: Part I Test reports). So there is no deleterious affection of safety and effectiveness about the difference on Battery with predicated device.
g. The seat height, width and depth for both devices are almost the same. They are all equipped with Removable and Flip Backward Armrest for users to leave the seats easily and more compact for storage.

The front wheel set of S542 is equipped with a leaf spring suspension. This makes the S542 more comfortable than the predicated device. The device has passed ISO 7176-2:2001(Determination of Dynamic Stability of electric wheelchairs) & ISO 7176-8 (Requirements and test methods for static, impact and fatigue strengths) test (Please see Appendix IV: Test reports). So there is no deleterious affection of safety and effectiveness about the difference on this suspension with the predicated device.

Conclusions

According to comparison table and discussions above, the differences on total weight, speed, battery size, suspension type and dimensions do not deleteriously affect the safety and effectiveness of the device.

So based on the design, performance specifications and testing and intended use, the Merits Yoga Power Scooter, S542, is substantially equivalent to the Merits Travel Ease Electric Scooter, Model Pioneer 5 (K013788).

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).