COMFORT SCOOTER MODEL LY-EW406 by COMFORT ORTHOPEDIC CO. LTD.

The COMFORT SCOOTER, LY-EW406 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 can be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

The Comfort Scooter, LY-EW406, is a motorized three-wheeled vehicle intended for medical purposes to provide mobility to persons restricted to a seated position.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Predicate Device K022369)	Reported Device Performance (LY-EW406)
Permissible Load Weight	265 lbs	265 lbs
Electronic Controller	UL Certified	UL Certified
Recharge System	UL Certified	UL Certified
Electrical Safety	ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 standards for electrically powered wheelchairs, controllers, and chargers	Compliant with ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995
Max Speed	4.0 mph (predicate)	4.2 mph
Intended Use	To provide mobility to persons restricted to a seated position	To provide mobility to persons restricted to a seated position

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

The submission does not detail a "test set" in the context of clinical data or comparative performance against a predefined set of cases/patients. The performance testing referenced is against engineering standards and comparison to a predicate device.
Data provenance: Taiwan, R.O.C. (Manufacturer location). The nature of the testing suggests it is primarily engineering/bench testing rather than clinical data, therefore it would be considered prospective for the device under test.

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

Not applicable. The study does not involve human expert interpretation of data for ground truth establishment. The "ground truth" for this device's performance is compliance with established electrical and wheelchair performance standards, and comparison of specifications to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. This type of adjudication method is usually for clinical studies with expert reviewers, which is not relevant for this device's submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices involving human interpretation of medical images or data. The Comfort Scooter is a mobility device; its performance is evaluated against engineering standards and functional specifications rather than clinical diagnostic accuracy.

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

Not applicable. This device is a physical product (electric scooter), not an algorithm or AI system. Its performance evaluation is based on direct measurements and adherence to specified standards.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is based on:

Engineering Standards: Compliance with recognized international and national standards for electrically powered wheelchairs and electrical safety (e.g., ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3).
Predicate Device Specifications: Direct comparison of key performance characteristics (e.g., load capacity, controller type, recharge system, maximum speed) to a legally marketed device (COMFORT AGILE SCOOTER LY-EW303, K022369) to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI for this device.

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

Not applicable. No training set was used.

Summary

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K063030
Page 1 of 2

MFORT 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

66 510(k) SUMMARY "

DEC = 4 2006

September 29, 2006

Submitter's Name: COMFORT ORTHOPEDIC CO., LTD.

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

Date summary prepared:

Device Name:

Proprietary Name: COMFORT SCOOTER, LY-EW406 Common or Usual Name: Electric Scooter Classification Name: Motorized 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/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)

. _ Legally marketed device for substantial equivalence comparison: COMFORT AGILE SCOOTER LY-EW303 (K022369)

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K063030
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OMFORT MFORT 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

Summary for substantial equivalence comparison:

The intended uses, the load weight limit 265 lbs, electronic controller, back upholstery and armrest types, and warranty period between the new device LY-EW303 and the predicate device LY-EW302 are the same. Especially the electronic controller and recharge between two devices are all passed by the UL certificated. Thus the same safety level for the two devices is assured.

The major difference existing is the new device is more agile than the predicate device. Besides the overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

The maximum speed is 4.2 mph for the new device and 4.0 mph for the predicate device that are also under the 6 miles maximum speed limited. Those speeds can be continuous adjusted by the throttle tiller. The operators can set the adequate speed according to their feeling and need, and the maximum speed differences do not mean any performance differences. They are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Comfort Orthopedic Co., Ltd. % Dr. Ki-Men Jen Roc Chinese European Industrial Research Society No. 120, Nan Shiange Tsuen, Shoei Shang Shiang, Chia-yi, Taiwan, R.O.C. 608

DEC - 4 2006

Re: K063030

Trade/Device Name: Comfort Scooter, LY-EW406 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. 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.

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 Ki-Men

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 yours,

Plok Dep Director

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo and contact information for Comfort Orthopedic Co., LTD. The company's website is listed as www.comfort.com.tw. The address is No. 120, Nan Shiang Tsuen, Shoei Shang Shiang, Chia-yi, Taiwan, R.O.C.608. The telephone number is 886-5-2892093, and the fax number is 886-5-2890070.

Indications for Use

510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________

Device Name: COMFORT SCOOTER, LY-EW406

Indications for Use:

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

Prescription Use(Part 21 CFR 801 Subpart D)
AND/OR	Over-The-Counter(21 CFR Part 807 Subpart C)

ver-The-Counter Use

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(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices	Page 1 of 1
510(k) Number	K063030

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).