The COMFORT SCOOTER, LY-E'V415 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device c in be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

The provided text describes a 510(k) submission for the COMFORT SCOOTER, LY-EW415, and focuses on demonstrating substantial equivalence to a predicate device, the COMFORT WINDJOY SCOOTER LY-EW302 (K022369). The "acceptance criteria" here refer to the performance and design characteristics that the new device must meet to be considered substantially equivalent to the predicate device. The study proving the device meets these criteria is the comparison summary provided by the manufacturer.

Here's a breakdown of the requested information:

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

The acceptance criteria are implicitly defined by the specifications of the predicate device. The study demonstrates that the new device (subject device) either meets these specifications directly or has differences that do not raise new questions of safety or effectiveness.

Acceptance Criteria (Predicate Device K022369)	Reported Device Performance (Subject Device K063032)	Justification/Comment
Intended Use: The device is intended for medical purposes to provide mobility to persons restricted to a seated position.	SAME	Substantially equivalent.
Overall Length: 48"	59.8" / 152 cm	New device is larger; applicant states this is "NOT related to the safe aspect" and that "larger dimensions can hold more mass and possess more balance," leading to "more safety."
Overall Width: 24.4"	28.3" / 72 cm	New device is larger; applicant states this is "NOT related to the safe aspect" and that "larger dimensions can hold more mass and possess more balance," leading to "more safety."
Max Loading: 265 lbs	180 kgs / 400 lbs	New device has higher maximum loading capacity. Implies improved safety for heavier users.
Electronics: Dynamic Rhino series	SAME	Substantially equivalent.
Batteries Type: Sealed lead acid, 40Ah 12VDC	Sealed lead acid, 75Ah 12VDC	Same type, but new device has higher capacity (75Ah vs 40Ah). Applicant states batteries are from the "same supplier and they are certificated by UL."
Range per Charge: 28 miles	75 km / 46.8 miles	New device has a significantly longer range per charge due to higher battery capacity.
Front Tires: 85 x 260 mm	4.00-5 (pneumatic)	Different specified dimensions/types of pneumatic tires. No safety concern raised.
Rear Tires: 4.10 / 3.50-5"	3.00-10 (pneumatic)	Different specified dimensions/types of pneumatic tires. No safety concern raised.
Maximum Speed: 5.5 mph	8 km / 5.0 mph	New device has a slightly lower maximum speed (0.5 mph difference). Applicant states this difference does "not mean any performance differences" and that "the new device has lower maximum speed, thus leading to more safety and less hazard."
Turning Radius: 43.3"	180 cm / 70.8"	New device has a larger turning radius. Related to overall dimension increase. No safety concern raised.
Back Upholstery: Fabric	SAME	Same material; applicant states it "passed the resistance ignition test by SGS."
Scooter Weight: 165 lbs (w/o battery)	140 kgs / 308 lbs (with battery)	New device is heavier (with battery compared to predicate's weight without battery). Implies robust construction.
Recharger: DC 24V 5A Remote	DC 24V 8A Remote	Same resource, both UL certified; difference in output current (8A vs 5A) leads to "charging period differences or arise from the different battery capacity, not related with safety aspect."
Safe Climbing Angle: 12°	SAME	Substantially equivalent.
Warranty (Main Frame): 3 years	SAME	Substantially equivalent.
Warranty (Controller / Gear Motor): 1 year	(Implicitly same, as the controller/motor are the same or similar)	Substantially equivalent for main components.

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

This is a design and performance comparison study against a predicate device, not a clinical study involving a test set of patients or data samples in the traditional sense of AI/diagnostic device evaluation. Therefore:

Sample size for test set: Not applicable. The "test set" consists of the specifications and performance characteristics of the subject device being compared.
Data provenance: Not applicable in the context of clinical data. The data originates from the manufacturer's engineering specifications, testing (e.g., EMC report, SGS ignition test), and component certifications (UL for batteries and chargers). The devices are manufactured in Taiwan, R.O.C.

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

Not applicable. Ground truth, in this context, refers to the established safety and performance of the predicate device, which has already been legally marketed. The assessment relies on engineering comparisons and regulatory standards, not expert clinical interpretation of test cases.

4. Adjudication method for the test set

Not applicable. There is no "test set" of cases requiring adjudication by experts. The comparison is based on objective specifications and performance testing.

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

Not applicable. This is not an AI/diagnostic device. It's a mobility scooter.

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

Not applicable. This is not an AI/diagnostic device. Performance testing involved direct engineering measurements and compliance with standards like ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers -- requirements and test methods).

7. The type of ground truth used

The "ground truth" used for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (COMFORT WINDJOY SCOOTER LY-EW302, K022369), as well as compliance with recognized performance standards for electric wheelchairs.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. There is no training set for this device.

Summary

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K063032

September 29, 2006

OMFORT OCT 1 6 2006 OMFORT ORTHOPEDIC CC., LTD. www.comfort.com.tw No.120,Nan Shiang Tsuen,Shoei SI ang Shiang,Chia-yi,Taiwan,R.O.C.608 TEL : 886-5-2892093 FAX : 886-5-2890070

દર 510(I:) SUMMARY "

Submitter's Name: COMFORT ORTHOPEI›IC CO., LTD.

N0. 120, NAN SHIANG TSUEN, SHOEI SHANG SHIANG, CHIA-YI, TAIWAN, ROC

Date summary prepared:

Device Name:

Proprietary Name: COMFORT SCOOTER, LY-EW415 Common or Usual Name: Electric Scooter Classification Name: Motor zed 3-Wheeled Vehicle, Class II, 21 CFR 890.3800

Indications for Use:

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

Description of the device:

Performance Testing:

EMC Report ANSI / RESNA WC/V ɔl.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers -- requirements and test met hods)

Legally marketed device for substantial equivilence comparison: COMFORT WINDJOY SCOOTER LY-EW302 (K022369)

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COMFORT COMFORT ORTHOPEDIC CO., LTD. www.comfort.com.tw No.120,Nan Shiang Tsuen,Shoei Shang Shiang,Chia-yi,Taiwan,R.O.C.608 TEL : 886-5-2892093 FAX : 886-5-2890070

C.1 SUMMARY TABLE

ITEMS	SUBJECT DEVICE	PREDICATEDEVICE 1
BRAND NAME	COMFORT	COMFORT
MANUFACTURER	COMFORT	COMFORT
SERIES	FUTURE	WINDJOY
MODEL NO	LY-EW415	LY-EW302
510K NO	TBA	K022369
INTENDED USE	SAME	The device isintended formedicalpurposes toprovide mobilityto personsrestricted to aseated position.
Overall dimension
Overall length	59.8" / 152 cm	48"
Overall width	28.3" / 72 cm	24.4"
Max loading	180 kgs / 400 lbs	265 lbs
Electronics	SAME	DynamicRhino series
Batteries
Quantity	Two	Two
Type	Sealed lead acid, 75Ah12VDC	Sealed lead acid, 40Ah12VDC
Range per charge	75 km / 46.8 miles	28 miles
ITEMS	SUBJECT DEVICE	PREDICATEDEVICE 1
Front tires	4.00-5 (pneumatic)	85 x 260 mm
Rear tires	3.00-10 (pneumatic)	4.10 / 3.50-5"
Maximum speed	8 km / 5.0 mph	5.5 mph
Turning radius	180 cm / 70.8"	43.3"
Back upholstery	SAME	Fabric
Scooter weight	140 kgs / 308 lbs( with battery )	165 lbs( w/o battery )
RECHARGER	DC 24V 8ARemote	DC 24V 5ARemote
Safe climbing angle	SAME	12°
Warranty
3 years	SAME	Main frame
1 year		Controller / gear motormain components w/oexhaustive and wear part

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COMFORT ORTHOPEDIC CO., LTD. www.comfort.com.tw No.120,Nan Shiang Tsuen,Shoei Shang Shiang,Chia-yi,Taiwan,R.O.C.608 TEL : 886-5-2892093 FAX : 886-5-2890070

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OMFORT COMFORT ORTHOPEDIC CO., LTD. www.comfort.com.tw No.120,Nan Shiang Tsuen,Shoei Shang Shiang,Chia-yi,Taiwan,R.O.C.608 TEL : 886-5-2892093 FAX : 886-5-2890070

C.2 COMPARISON SUMMARY

( We place the related information for the predicate device in the following pages. )

The overall dimensions and visional appearance are similar, and the dimensions for the new device are larger than that of the predicate device. The device of the smaller dimensions can be fitted into most of the ordinary car trunk. Our new device may not be fitted into small car trunk, but this is NOT related to the safe aspect. Besides, a device of larger dimensions can hold more mass and possess more balance. It certainly has more safety during moving and turning.

The batteries used are same supplier and they are certificated by UL. The control systems for the two devices are same supplier; it is Dynamic Rhino series controller types for the two devices. The recharge for the two devices are also used the same resource and they are certified by UL. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. The safety and performance functions of two systems are assured and validated. They are substantially equivalent.

The maximum speed is 0.5 mph difference for the two devices. The throttle tiller can continuously adjust the speeds. The operators can set the adequate speed according to their feeling and need, i.e., outdoor or indoor, and the maximum speed differences do not mean any performance differences. The new device has lower maximum speed, thus leading to more safety and less hazard. They are substantially equivalent.

The battery chargers types are almost the same; only for the output electric current is 8A for the new device and 5A for the predicate device. The current differences lead to the charging period differences or arise from the different battery capacity, not related with safety aspect.

Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and only minor differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Public Health Service

OCT 1 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Comfort Orthopedic Co., Ltd. % Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, China (Taiwan) 30067

Re: K063032

Trade/Device Name: Comfort Scooter, LY-EW415 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 29, 2006 Received: October 3, 2006

Dear Dr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Dr. Jen Ke-Min

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Morgan Buckner

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510 (K) Number ( If Known ):_ र

Device Name: COMFORT SCOOTER, LY-EW415

Indications for Use:

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

Prescription Use

AND/OR

Over-The-Counter Use √

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Malvare Buellin

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-On) Division of General, Restorative, and Neurological Devices

510(k) Number K063037

Page 1 of 1

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).