The WU'S Powered Wheelchair MAMBO 36X is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armirests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembly d for transport and is provided with an onboard battery charger.

AI/ML Overview

This document describes a 510(k) premarket notification for a powered wheelchair, the WU'S POWERED WHEELCHAIR, MAMBO 36X (later changed to FORYOU POWER WHEELCHAIR, FC-100). The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, many of the requested categories related to acceptance criteria, ground truth, expert review, and sample sizes for a performance study are not directly applicable or available in this type of submission. The "study" mentioned is a comparison to a legally marketed device to establish substantial equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not typically presented for a 510(k) submission showing substantial equivalence for a powered wheelchair. The "acceptance criteria" here are generally compliance with relevant standards and demonstrating equivalence in key performance characteristics to a predicate device, rather than quantitative performance targets.

Acceptance Criteria Category	Reported Device Performance (or Equivalence Claim)
Intended Use	"To provide mobility to persons restricted to a seated position." (Claimed same as predicate device)
Mainframe Foldability	Foldable (Claimed same as predicate device)
Mainframe Materials	Meet strength and fatigue tests; similar materials (Claimed same as predicate device)
Cross Brace Suspension	Same as predicate device
Armrest Type	Same as predicate device
Back Upholstery Material	Same fabric as predicate device ---------------------------------------------
Electronic Systems	Same suppliers as predicate device, all UL certified for safety (controller, batteries, charger).
EMC/Electrical Safety	Compliant with ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995.

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

Sample Size: Not applicable. No "test set" in the sense of patient data or clinical images was used. The substantial equivalence was based on a comparison of device specifications, materials, and compliance with performance standards.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. No ground truth based on expert review was established for this submission. The "ground truth" for substantial equivalence is the predicate device's characteristics and its prior clearance.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This is a medical device clearance based on substantial equivalence, not an AI efficacy study.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No. This device is a physical product (powered wheelchair), not an algorithm. Performance refers to mechanical and electrical safety standards compliance.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this 510(k) submission is the characteristics and performance of the legally marketed predicate device (TEH LIN JUPITER Powered Wheelchair TL-320 (K022697)) and compliance with relevant performance standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995).

8. Sample Size for the Training Set

Sample Size: Not applicable. There is no AI model or "training set" for a powered wheelchair.

9. How Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable.

Summary

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JUL - 6 2006

K061693

NO. 225, YUAN-PIER ST., HSIN C TEL: 886-3-5382105 FAX . 886-3-5387 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net

FEB 1 1 2005

6 < 510(k) SUMMARY "

Submitter's Name: WU'S TECH CO., LTD.

NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) Tel: 88

Date summary prepared:

December 30, 2004

·Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

WU'S POWERED WHEELCHAIR, MAMBO 36X POWERED WHEELCHAIR POWERED WHEELCHAIR, Class II, 21 CFR 890.3860

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, scooters, and th chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: TEH LIN JUPITER Powered Wheelchair TL-320 (K022697)

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NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) TEL: 886-3-5382105 FAX: 886-3-53821 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net

Summary for substantial equivalence comparison;

The intended use between the two devices is the same. Mainframes of two devices are foldable. Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The suspension of cross brace is the same. The two devices used the same type of armrest. Back upholstery material is also the same fabric. Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, Thus the same safety level for the two devices is assured. batteries, and recharge,

The major differences existing are the overall dimension, the size of seat, weight limit, maximum speed, cruising range, and the incline degrees is differences between the two devices. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the edge. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2006

FORYOU TECHNOLOGY CO., LTD. % ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY Dr. Ke-Min Jen No. 58 Fu-Chiun St. Hsin-Chu City China (Taiwan) 30067

Re: K061693

Trade/Device Name: FORYOU POWER WHEELCHAIR, FC-100 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulation Class: II Product Code: ITI Dated: June 12, 2006 Received: June 15, 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 reclass fied in accordance with the provisions of the Federal Food, Drug, and Commenc 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, of the echner. 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 mec publish further announcements concerning your device in the Eederal 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 Art 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 (2) CFR Parp (2) ); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the anality 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. Ke-Min Jen

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.

fabaybmon

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 ): K 061693

Device Name: FORYOU POWER WHEELCHAIR, FC-100

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 NEED

Concurrence of CDRH, Office of Device Evaluation (ODE)
K061693 (haubeixunno for huan

Division of General, Restorative. and Neurological Devices

Page l の

510(k) Number K011693

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).