Wu's Electrical Scooter

• K Number: K192308
• Device Name: Wu's Electrical Scooter
• Manufacturer: Wu's Tech Co., Ltd.
• Date Cleared: 2020-12-21 ( 483 days)
• Product Code: INI
• Regulation Number: 890.3800

Intended Use

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

Device Description

The Wu's Electrical Scooter, WT-M4JKx, is an indoor-use electrical scooter that is battery operated. It has a base with 4 wheels, a seat and 2 armrests. The movement of the electrical scooter is controlled by the rider who uses speed control lever to control the direction and speed of an electrical scooter. The motor power is 470W. The device uses a PG S-Drive 70A electronic controller. The device is provided with an off-board battery charger (Input: AC100-240V, Output: DC 24V, 5 Amp). The maximum weight capacity of WT-M4JKx is 400 lbs (182 kg), and its maximum forward speed is 5.9 mph (9.5 km/h).

Predicate Devices

K032489

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard electrical scooter components and safety/performance testing according to established standards. There is no mention of AI, ML, or any features that would suggest intelligent decision-making or learning capabilities.

Therapeutic

No.
A therapeutic device intends to treat or cure a disease or condition, and this device provides mobility support rather than treatment.

Diagnostic

No

The device description clarifies that its purpose is to provide mobility. It does not mention any function related to diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components such as a base with wheels, a seat, armrests, a motor, an electronic controller, and a battery charger. The performance studies also focus on testing the physical characteristics and safety of the scooter.

IVD (In Vitro Diagnostic)

No, 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 describes a device used on a person for physical support and movement, not a device used to test samples from a person (like blood, urine, or tissue) to diagnose or monitor a medical condition.
• Device Description: The description details a physical mobility device (scooter) with components like wheels, a seat, armrests, a motor, and a battery. These are all components of a physical mobility aid, not an IVD.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples.
  • Detecting or measuring substances in samples.
  • Providing diagnostic or monitoring information based on sample analysis.
  • Reagents or assays.

The device described is a mobility aid, which falls under a different category of medical devices than IVDs.

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 (comma separated list FDA assigned to the subject device)

INI

Device Description

The Wu's Electrical Scooter, WT-M4JKx, is an indoor-use electrical scooter that is battery operated. It has a base with 4 wheels, a seat and 2 armrests. The movement of the electrical scooter is controlled by the rider who uses speed control lever to control the direction and speed of an electrical scooter. The motor power is 470W. The device uses a PG S-Drive 70A electronic controller. The device is provided with an off-board battery charger (Input: AC100-240V, Output: DC 24V, 5 Amp). The maximum weight capacity of WT-M4JKx is 400 lbs (182 kg), and its maximum forward speed is 5.9 mph (9.5 km/h).

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Testing:

• ISO 7176-16:2012 - Wheelchairs - Part 16: Resistance to ignition of postural support devices.
• ISO 7176-25: 2013 - Wheelchairs - Part 25: Batteries and Chargers for Powered Wheelchairs
• RESNA WC-1 Section 1:2009
• RESNA WC-1 Section 2:2009
• RESNA WC-1 Section 3:2009
• RESNA WC-1 Section 4:2009
• RESNA WC-1 Section 5:2009
• RESNA WC-1 Section 6:2009
• RESNA WC-1 Section 7:2009
• RESNA WC-1 Section 10:2009
• RESNA WC-1 Section 11:2009
• RESNA WC-1 Section 13:2009
• ISO 7176-15:1996
• ISO 7176-14:2008

Biocompatibility evaluation of patient-contacting parts:

• Headrest Seatback Seat leather Safety belt (PVC Vinyl & Color additive: Diphenylmeth-ane 4): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: Cytotoxicity, Sensitization, Skin Irritation tests based on ISO 10993-1:2009.
• Armrest (PU Foam & Color additive: Diphenylmeth-ane 4): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: Cytotoxicity, Sensitization, Skin Irritation tests based on ISO 10993-1:2009.
• Horn button (Dow Corning RBB-6671-70 + RBB-6671-70+ XE20-523-5U + Colourant Techi Black 1801 & Color additive: Solvent Yellow): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: Cytotoxicity + skin Irritation & delayed-type hypersensitivity (Epicutan test) Tests based on ISO 10993-5:2009, ISO 10993-10:2013.
• Speed dial (Makrolon 6557 (PC material) & Color additive: Carbon black): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: Cytotoxicity test based on ISO 10993-5:2009.
• REM060/1 10 bottom case (Makroblend EL700 (PC+PET materials) & Color additive: Carbon black): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: Cytotoxicity + Skin irritation & delayed-type hypersensitivity (Epicutan test) Tests based on ISO 10993-5:2009, ISO 10993-10:2013.
• REM050/1 00 (Full joystick control module) (Makroblend EL 700 + Makrolon 6557 & Color addtitive: Carbon black): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: Skin irritation and delayed-type hypersensitivity Tests (Epicutan test) based on ISO 10993-10:2013.
• Footrest (Polylac ABS & Color additive: Carbon black): Indirect contact / Surface contacting less than 24 hours duration; Tests conducted: MSDS. Rationale: Polylac ABS material is a common and mature material for wheelchair's part, and was adopted by many wheelchair manufacturers in the current market. There are no customer claims with adverse conditions for more than thousands of units sold in the market according to our sale experience.
• Delta handle bar (PVC Vinyl & Color additive: Polyol, Pigment): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: Cytotoxicity, Skin irritation, Sensitization based on ISO 10993-5:2009, ISO 10993-10:2010.
• Speed lever (ε-Caprolactam resin): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: Cytotoxicity, Skin irritation, Sensitization based on ISO 10993-5:2009, ISO 10993-10:2010.
• Light switch (Polyamide -6 & Color additive: Solvent 37): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: MSDS. Rationale: Low frequency of human contact and no customer claims with adverse conditions according to previous sale experience and our expertise.
• Indicator switch (Phenolic & Color additive: Carbon black): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: MSDS. Rationale: Low frequency of human contact and no customer claims with adverse conditions according to previous sale experience and our expertise.
• Emergency switch (Phenolic & Color additive: Solvent red 135): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: MSDS. Rationale: Low frequency of human contact and no customer claims with adverse conditions according to previous sale experience and our expertise.
• Delta handle bar knob (Polylac & Color additive: Carbon black): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: MSDS. Rationale: Low frequency of human contact and no customer claims with adverse conditions according to previous sale experience and our expertise.
• Seat remove lever (Polyvinyl Chloride & Color additive: Polyol, Pigment): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: MSDS. Rationale: Low frequency of human contact and no customer claims with adverse conditions according to previous sale experience and our expertise.
• Seat slide lever (ε-Caprolactam resin): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: MSDS. Rationale: Low frequency of human contact and no customer claims with adverse conditions according to previous sale experience and our expertise.
• Freewheel lever (Polyvinyl chloride & Color additive: Solvent Yellow): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: MSDS. Rationale: Low frequency of human contact and no customer claims with adverse conditions according to previous sale experience and our expertise.
• Charging socket cover (ε-Caprolactam resin): Direct contact / Surface contacting less than 24 hours duration; Tests conducted: MSDS. Rationale: Low frequency of human contact and no customer claims with adverse conditions according to previous sale experience and our expertise.

RESNA standard tests comparison table and discussions (Subject device WT-M4JKx compared to predicate device WT-M4Jr K032489):

• Static stability downhill (Max.): Subject Device: RESNA WC/Vol.1 Section 1:2009, Result: 26°. Predicate Device: RESNA WC/Vol.1 Section 1:1998, Result: NA. (Subject device showed larger static stability)
• Static stability downhill (Min.): Subject Device: RESNA WC/Vol.1 Section 1:2009, Result: 16°. Predicate Device: RESNA WC/Vol.1 Section 1:1998, Result: 12°. (Subject device showed larger static stability)
• Static stability uphill (Max.): Subject Device: RESNA WC/Vol.1 Section 1:2009, Result: 16°. Predicate Device: RESNA WC/Vol.1 Section 1:1998, Result: NA. (Subject device showed larger static stability)
• Static stability uphill (Min.): Subject Device: RESNA WC/Vol.1 Section 1:2009, Result: 15°. Predicate Device: RESNA WC/Vol.1 Section 1:1998, Result: 11°. (Subject device showed larger static stability)
• Static stability sideways (Max.): Subject Device: RESNA WC/Vol.1 Section 1:2009, Result: 9.5°. Predicate Device: RESNA WC/Vol.1 Section 1:1998, Result: 9°. (Subject device showed larger static stability)
• Dynamic stability downhill: Subject Device: RESNA WC/Vol.1 Section 2:2009, Result: 6°. Predicate Device: RESNA WC/Vol.1 Section 2:1998, Result: 10°. (Subject device has 4-degree less dynamic stability, mitigated by ADAAG slope requirements and user manual disclosure.)
• Minimum braking distance from max speed: Subject Device: RESNA WC/Vol.1 Section 3:2009, Result: 1.4m. Predicate Device: RESNA WC/Vol.1 Section 3:1998, Result: 1.15m. (Subject device needs 0.25m more braking distance due to higher max speed, information disclosed in user manual.)
• Cruising range: Subject Device: RESNA WC/Vol.1 Section 4:2009, Result: 29km. Predicate Device: RESNA WC/Vol.1 Section 4:1998, Result: 32km. (Shorter cruising range for subject device, user manual disclosure of 18 miles (29 km) range.)
• Overall length: Subject Device: RESNA WC/Vol.1 Section 5:2009, Result: 1210mm. Predicate Device: RESNA WC/Vol.1 Section 5:1998, Result: 1170mm. (Minor difference, not safety related.)
• Overall width: Subject Device: RESNA WC/Vol.1 Section 5:2009, Result: 580mm. Predicate Device: RESNA WC/Vol.1 Section 5:1998, Result: 560mm. (Minor difference, not safety related.)
• Total mass: Subject Device: RESNA WC/Vol.1 Section 5:2009, Result: 85.5kg. Predicate Device: RESNA WC/Vol.1 Section 5:1998, Result: 43kg. (Heavier for subject device due to bigger size, leads to more comfortable feeling and less cruising range, no new safety concerns.)
• Minimum turning radius: Subject Device: RESNA WC/Vol.1 Section 5:2009, Result: 1400mm. Predicate Device: RESNA WC/Vol.1 Section 5:1998, Result: 1100mm. (Larger for subject device, disclosed in user manual.)
• Minimum turn-around width: Subject Device: RESNA WC/Vol.1 Section 5:2009, Result: 1600mm. Predicate Device: RESNA WC/Vol.1 Section 5:1998, Result: 1200mm. (Larger for subject device, disclosed in user manual.)
• Maximum speed forward: Subject Device: RESNA WC/Vol.1 Section 6:2009, Result: 9.5km. Predicate Device: RESNA WC/Vol.1 Section 6:1998, Result: 6.4km. (Higher speed for subject device, requires more braking distance, disclosed in user manual.)
• Seat plane angle (Max.): Subject Device: RESNA WC/Vol.1 Section 7:2009, Result: 5°. Predicate Device: RESNA WC/Vol.1 Section 7:1998, Result: 0°. (Difference results in backward inclination or less forward tip-over chance, no new safety concerns.)
• Effective seat depth: Subject Device: RESNA WC/Vol.1 Section 7:2009, Result: 430mm. Predicate Device: RESNA WC/Vol.1 Section 7:1998, Result: 420mm. (Minor difference, comfort related, not safety related.)
• Effective seat width: Subject Device: RESNA WC/Vol.1 Section 7:2009, Result: 460mm. Predicate Device: RESNA WC/Vol.1 Section 7:1998, Result: 430mm. (Minor difference, comfort related, not safety related.)
• Seat surface height at front edge (Min./Max.): Subject Device: RESNA WC/Vol.1 Section 7:2009, Result: 570mm/620mm. Predicate Device: RESNA WC/Vol.1 Section 7:1998, Result: 500mm/500mm. (Adjustable seat height for subject device, not safety related.)
• Obstacle climbing (Max.): Subject Device: RESNA WC/Vol.1 Section 10:2009, Result: 50mm. Predicate Device: RESNA WC/Vol.1 Section 10:1998, Result: 50mm. (Same.)
• Obstacle climbing (Min.): Subject Device: RESNA WC/Vol.1 Section 10:2009, Result: 15mm. Predicate Device: RESNA WC/Vol.1 Section 10:1998, Result: 20mm. (Minor difference, disclosed in user manual.)
• Footrest to seat distance (Max./Min.): Subject Device: ISO7176-15:1996, Result: 475mm/425mm. Predicate Device: ISO7176-15:1996, Result: 460mm/410mm. (Adjustable, comfort related, not safety related.)
• Front location of armrest structure: Subject Device: ISO7176-15:1996, Result: 320mm. Predicate Device: ISO7176-15:1996, Result: 305mm. (15mm larger for subject device due to overall design, not safety related.)

Key results from non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K032489

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 21, 2020

Wu's Tech Co., Ltd. % Jen Ke-Min Chinese-European Industrial Research Society No. 58, Fu-Chiun St Hsin-Chu City, Hsinchu 30067 Taiwan

Re: K192308

Trade/Device Name: Wu's Electrical Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: September 29, 2020 Received: October 5, 2020

Dear Jen 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Heather Dean, Ph.D. Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192308

Device Name

Wu's Electrical Scooter. WT-M4JKx

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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows a logo for "WU'S Tech". The logo is inside of a green rounded rectangle. The text "WU'S" is in red, and the word "Tech" is in black.

五氏科技股份有限公司
WU'S TECH CO., LTD

5382191 lenhone/886-3-5382105 .225 Yuan Peir St. Hsinchu, Taiwan R -MAIL:[e-mail]

510(k) Summary of Safety and Effectiveness

(per 21 CFR 807.92)

Submitter's Name:	Wu's Tech Co., Ltd.
	No.225, Yuan Peir St., Hsinchu, Taiwan ROC 30093
Date summary prepared:	December 11, 2020
Proprietary Name:	Wu's Electrical Scooter, WT-M4JKx
Common or Usual Name:	Electrical Scooter
Classification Name	Motorized 3-Wheeled Vehicle
	Class II, 21 CFR 890.3800
Product Code:	INI
Contact Person:	Dr. Jen, Ke-Min
Email:	[e-mail]
	TEL: [phone], FAX: [phone]
Predicate Device	Wu's Tech Co., Ltd.
	Wu's Electrical Scooter, WT-M4Jr
	K032489

Indications for Use: ●

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

● Device Description:

The Wu's Electrical Scooter, WT-M4JKx, is an indoor-use electrical scooter that is battery operated. It has a base with 4 wheels, a seat and 2 armrests. The movement of the electrical scooter is controlled by the rider who uses speed control lever to control the direction and speed of an electrical scooter. The motor power is 470W. The device uses a PG S-Drive 70A electronic controller. The device is provided with an off-board battery charger (Input: AC100-240V, Output: DC 24V, 5 Amp). The maximum weight capacity of WT-M4JKx is 400 lbs (182 kg), and its maximum forward speed is 5.9 mph (9.5 km/h).

4

Image /page/4/Picture/0 description: The image shows a logo with the text "WiU's Tech" in red letters. The letters are stylized and have a rounded appearance. The logo is enclosed in a green rounded rectangle. The word "Tech" is smaller and located below the "WiU's" part of the logo.

統一編號/70711910 新竹市元培街225號 FAX /886-3-5382191 Telephone/886-3-5382105 No.225 Yuan Peir St. Hsinchu, Taiwan R.O.C. E-MAIL:[e-mail]

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 6 degrees.
• Ground clearance to battery: 1.77"/45 mm
• Curb climbing ability: 1.96"/50 mm
• Compliant Testing Standards

Safety standards:

• RESNA WC-1:2009 Wheelchairs - Volume 1 Requirements and test methods for wheelchairs (including scooter)

• RESNA WC-2:2009 Wheelchairs - Volume 2 Additional requirements for wheelchairs (including scooter) with electrical systems

EMC standard:

• RESNA WC-2:2009 Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters

Bench Testing:

• ISO 7176-16:2012 - Wheelchairs - Part 16: Resistance to ignition of postural support devices.

• く ISO 7176-25: 2013 - Wheelchairs - Part 25: Batteries and Chargers for Powered Wheelchairs
• イ RESNA WC-1 Section 1:2009
• く RESNA WC-1 Section 2:2009
• く RESNA WC-1 Section 3:2009
• イ RESNA WC-1 Section 4:2009
• く RESNA WC-1 Section 5:2009
• く RESNA WC-1 Section 6:2009
• く RESNA WC-1 Section 7:2009
• イ RESNA WC-1 Section 10:2009
• イ RESNA WC-1 Section 11:2009
• イ RESNA WC-1 Section 13:2009
• イ ISO 7176-15:1996
• イ ISO 7176-14:2008

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Image /page/5/Picture/0 description: The image is a logo for "WiLi'S Tech". The logo is in red and green, with the text "WiLi'S" in large, bold letters. The word "Tech" is in smaller letters below "WiLi'S". The logo has a rounded rectangular border around it. The logo appears to be for a technology company.

●

伍氏科技股份有限公司
WU'S TECH CO., LTD

統一編號/70711910 新竹市元培街225號 新刊サポリンセーム(3)-----------------------------------------------------------------------------------------------------------------------------------------------------------------No.225 Yuan Peir St. Hsinchu,Taiwan R.O.C. E-MAIL:[e-mail]

Biocompatibility evaluation of patient-contacting parts

Patient-contacting Parts	Material's name & Color additive	Direct or Indirect contact / Contact classification & contact duration	Tests conducted	Rational for the tests conducted
1. Headrest Seatback Seat leather Safety belt	PVC Vinyl & Color additive: Diphenylmeth-ane 4	Direct-contact / Surface contacting less than 24 hours duration	Cytotoxicity
Sensitization
Skin Irritation tests	ISO 10993-1:2009
2. Armrest	PU Foam & Color additive: Diphenylmeth-ane 4	Direct-contact / Surface contacting less than 24 hours duration	Cytotoxicity
Sensitization
Skin Irritation tests	ISO 10993-1:2009
3. Horn button	Dow Corning RBB-6671-70 + RBB-6671-70+ XE20-523-5U + Colourant Techi Black 1801 & Color additive: Solvent Yellow	Direct-contact / Surface contacting less than 24 hours duration	Cytotoxicity + skin Irritation & delayed-type hypersensitivity (Epicutan test) Tests	ISO 10993-5:2009
ISO 10993-10:2013
4. Speed dial	Makrolon 6557 (PC material ) & Color additive: Carbon black	Direct-contact / Surface contacting less than 24 hours duration	Cytotoxicity test	ISO 10993-5:2009
5. REM060/1 10 bottom case	Makroblend EL700 (PC+PET materials) & Color additive: Carbon black	Direct-contact / Surface contacting less than 24 hours duration	Cytotoxicity + Skin irritation & delayed-type hypersensitivity (Epicutan test) Tests	ISO 10993-5:2009
ISO 10993-10:2013
6. REM050/1 00 (Full joystick control module)	Makroblend EL 700 + Makrolon 6557 & Color addtitive: Carbon black	Direct contact / Surface contacting less than 24 hours duration	Skin irritation and delayed-type hypersensitivity Tests (Epicutan test)	ISO 10993-10:2013
7. Footrest	Polylac ABS & Color additive: Carbon black	Indirect-contact / Surface contacting less than 24 hours duration	MSDS	*Polylac ABS material is a common and mature material for wheelchair's part, and was adopted by many wheelchair manufacturers in the current market.
*There are no customer claims with adverse conditions for more than thousands of units sold in the market according to our sale experience.
8. Delta handle bar	PVC Vinyl & Color additive: Polyol, Pigment	Direct-contact / Surface contacting less than 24 hours duration	Cytotoxicity
Skin irritation
Sensitization	ISO 10993-5:2009
ISO 10993-10:2010
9. Speed
lever	ε-Caprolactam resin	Direct-contact /
Surface
contacting less
than 24 hours
duration	Cytotoxicity
Skin irritation
Sensitization	ISO 10993-5:2009
ISO 10993-10:2010
10. Light
switch	Polyamide -6 &
Color additive:
Solvent 37	Direct-contact /
Surface
contacting less
than 24 hours
duration	MSDS	*Low frequency of
human contact and no
customer claims with
adverse conditions
according to previous sale
experience and our
expertise
11.
Indicator
switch	Phenolic & Color additive: Carbon black	Direct-contact /
Surface
contacting less
than 24 hours
duration	MSDS	*Low frequency of
human contact and no
customer claims with
adverse conditions
according to previous sale
experience and our
expertise
12.
Emergenc
y switch	Phenolic & Color additive: Solvent red 135	Direct-contact /
Surface
contacting less
than 24 hours
duration	MSDS	*Low frequency of
human contact and no
customer claims with
adverse conditions
according to previous sale
experience and our
expertise
13. Delta
handle
bar knob	Polylac & Color additive: Carbon black	Direct-contact /
Surface
contacting less
than 24 hours
duration	MSDS	*Low frequency of
human contact and no
customer claims with
adverse conditions
according to previous sale
experience and our
expertise
14. Seat
remove
lever	Polyvinyl Chloride & Color additive:
Polyol ,Pigment	Direct-contact /
Surface
contacting less
than 24 hours
duration	MSDS	*Low frequency of
human contact and no
customer claims with
adverse conditions
according to previous sale
experience and our
expertise
15. Seat
slide lever	ε-Caprolactam
resin	Direct-contact /
Surface
contacting less
than 24 hours
duration	MSDS	*Low frequency of
human contact and no
customer claims with
adverse conditions
according to previous sale
experience and our
expertise
16.
Freewhee
l lever	Polyvinyl chloride & Color additive:
Solvent Yellow	Direct-contact /
Surface
contacting less
than 24 hours
duration	MSDS	*Low frequency of
human contact and no
customer claims with
adverse conditions
according to previous sale
experience and our
expertise
17.
Charging
socket
cover	ε-Caprolactam
resin	Direct-contact /
Surface
contacting less
than 24 hours
duration	MSDS	*Low frequency of
human contact and no
customer claims with
adverse conditions
according to previous sale
experience and our
expertise

6

Image /page/6/Picture/0 description: The image shows a logo with the text "WU'S Tech" in red letters. The letters "WU" are connected, and there are two green dots above the "U". The text "Tech" is smaller and located below the "S". The logo is surrounded by a green border with rounded corners.

国限公司 O.. ILITD

新竹市元培街225號

統一編號/70711910
FAX :[phone]

新竹市元培街225號 No.225 Yuan Peir St. Hsinchu,Taiwan R.O.C. E-MAIL:[e-mail]

7

Image /page/7/Picture/0 description: The image shows a logo with the text "WU'S Tech" in red with a green border. The "WU'S" part of the logo is larger and more prominent than the "Tech" part. The logo has a rounded rectangular shape.

伍氏科技股份有限公司
WU'S TECH CO., LTD

統一編號/70711910 新竹市元培街225號 FAX /886-3-5382191 Telephone/886-3-5382105 No.225 Yuan Peir St. Hsinchu, Taiwan R.O.C. E-MAIL:[e-mail]

Specifications comparison table ●

| Model

Specification	Predicate Device	Subject Device
Manufacturer	Wu's Tech Co., Ltd.	Same
Proprietary name, model	Wu's Electrical Scooter,
WT-M4Jr	Wu's Electrical Scooter,
WT-M4JKx
510(k) number	K032489	TBA
Device classification name	Motorized 3-wheeled vehicle	Motorized 3-wheeled vehicle
Classification regulations	Class II, 21 CFR 890.3800	Class II, 21 CFR 890.3800
Product code	INI	INI
	Same or Similarity
Indications for 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.
Number of Wheels	4	4
Movement Control Method	Speed control lever	Speed control lever
Driving System	Direct drive rear wheel
(with differential gear)	Direct drive rear wheels
(with differential gear)
Brake System	Electromagnetic brake	Electromagnetic brake
Charger type	Off-board charger
Input: AC 100-240 V,
Output: DC 24V, 5A	Off-board charger
Input AC: 100-240V,
Output DC 24V, 5 Amp
Electronic Controller	PG S-Drive 70A	PG S-Drive 70A
Operating environments	Indoor use	Indoor use
Differences
Front Wheel Size	2.5 - 4" solid tire	10.2"x3.3" solid tire
Rear Drive Wheel Size	2.5 - 4" solid tire	10.2" × 3.3" solid tire
Dimension (LxW x D inch)	46 x 22 x 35.4 inches	40.6 × 23.8 × 49 inches
(LxW x D mm)	1170 × 560 × 900 mm	1210 × 580 × 1040 mm
Motor Output	350W × 24V × 1 pcs	470W x 24V x 1 pcs
Weight with Battery	94.7 lbs. /43 kg	188.1 lbs. / 85.5 kg
Cruising Range	20 miles /32 km	18 miles / 29 km
Battery type	34 Ah × 12V × 2 pcs	36 Ah × 12V × 2 pcs
Slope Grade Ability	10	6°
Max Speed Forward	4 mph (6.4 km/h)	5.9 mph (9.5 km/h)
Max Loading	250 lbs. (113.5 kg )	400 lbs. (182 kg)
Folding mechanism	No folding function	Foldable backrest and armrests

Specification comparison discussions ●

Both devices have the same indications for use, same technological designs, same number of wheels, same speed control lever, same driving system, and same brake system,

In the below, we discuss the differences between them,

8

Image /page/8/Picture/0 description: The image is a logo for a company called "Wi's Tech". The logo is in a green rounded rectangle. The text "Wi's" is in red, with two green dots above the "i" and the "s". The word "Tech" is in black and is located below the "s".

• √ Wheel size: The wheel sizes for the predicate and subject devices are different. The predicate device's tires are 2.5'' x 4" solid tires and the subject device's tires are 10.2"x3.3" solid tire. The wheels of predicate device are smaller than those of the subject device. Larger wheel will give more comfort to the users, and will not raise any safety and effectiveness concerns due to the different wheel size.
• Dimensions: The dimensions of the two devices are different. The larger depth will > give more support to the legs and will bring more comfort to user's ride, and since the subject device has passed the RESNA WC-1 and RESNA WC-2 standards with respect to safety and performance aspects, and this difference does not raise any new safety and effectiveness concerns for the subject device.

• Weight of wheelchair: The weight of subject device is 188.1 lbs. (85.5 kg) and it is heavier than the predicate device. This difference will make a lower ratio of the wheelchair weight/motor power output for the subject device. The ratio of the weight/power for the subject device is 188.1 1bs / 470 W = 0.400 lbs/W and the predicate device is 94.7 lbs/ 350 W = 0.270 lbs./W. The subject device will use one ioule energy per second to push 0.400 pounds of wheelchair weight, and the predicate device will use one joule energy per second to push 0.270 pounds of wheelchair weight. That is to say, the subject device consumes more battery's electrical energy than the predicate device. There are no new safety and effectiveness concerns raised for the subject device with respect to the larger weights.

• ✓ Motor output: The motor output for the subject device is 470W, it is larger than 350W of the predicate device. Since the volume and weight of the subject device is larger than the predicate device, the motor output of the subject device should be designed to be larger than the predicate device. The difference will not raise any new safety and effectiveness concerns for the subject device.
• V Cruising range: In general, the cruising range depends on the wheelchair weight, battery charging condition, motors output, and cruising surface conditions. The cruising range of the subject device is 18 miles and that of the predicate device is about 20 miles. The difference between subject device and predicate device is not large. As the user knew the cruising range of the subject device is 18 miles from the user manual, they will drive the scooter in consideration of 18 miles range, and avoid driving exceeding this cruising range for each travel. There are no new safety

9

Image /page/9/Picture/0 description: The image is a logo for a company called "WU'S Tech". The logo is red text with a green border. The text is in a bold, sans-serif font. The word "WU'S" is on the top line, and the word "Tech" is on the bottom line.

新竹市元培街225號 統一編號/70711910 Telephone/886-3-5382105 FAX /886-3-5382191 No.225 Yuan Peir St. Hsinchu, Taiwan R.O.C. E-MAIL:[e-mail]

and effectiveness concerns raised due to this smaller cruising range.

• ✔ Battery type: The battery capacity of the subject device is 36 Ah and the predicate device is 34 Ah. A larger battery capacity means this battery can drive a larger range or last for a longer time. Also, the batteries of the subject device have passed the testing of ISO 7176-25:2013. These facts demonstrate there are no any new safety and effectiveness concerns raised due to using a larger battery.

• Slope grade ability: The slope grade ability is 10 degrees for predicate device and 6 degrees for subject device. The relevant statement of 6 degrees for the slope grade ability is placed in the user manual. If the user operates the electrical scooter according to the instructions for use, any safety and effectiveness concerns are not raised due to the smaller slope grade ability.

• The Max Speed Forward for the subject device is 5.9 mph, which is larger than 4 mph of the predicate device. As we know the maximum safety speed for the motorized scooter is 6 mph, there is no safety and effectiveness concerns for the difference of maximum forward speed.

• The maximum loading of the subject device is 400 lbs. (182 kg) and it is 250 lbs (113.5 kg) for the predicate device. The maximum loading of the subject device is much larger than the predicate device, which will bring more comfort and safety to the users. There is no any new safety and effectiveness concerns due to the difference of the maximum loading for the subject device.

• The backrest and armrests of the subject device are foldable and the predicate device has no any folding function. These more functions bring more conveniences of storage or transportation than the predicate device. There are no any safety and effectiveness concerns raised for the subject device due to the differences of folding functions.

10

Image /page/10/Picture/0 description: The image shows a logo with the text "WU'S Tech" in red letters with green accents. The letters are stylized and have a rounded appearance. The word "Tech" is smaller and located below the "WU'S" part of the logo. The entire logo is enclosed in a rounded green border.

in

統一編號/70711910 新竹市元培街225號 新刊サポリントロッコース-5382105 FAX /886-3-5382191 No.225 Yuan Peir St. Hsinchu,Taiwan R.O.C. E-MAIL:[e-mail]

● RESNA standard tests comparison table

	Predicate Device:		Subject Device:
	Wu's Electrical Scooter,		Wu's Electrical Scooter,
Specification	WT-M4Jr		WT-M4JKx
	K032489		K192308
	Test Standard	Result	Test Standard	Result
Static stability downhill
(Max.)	RESNA WC/Vol.1
Section 1:1998	NA	RESNA WC/Vol.1
Section 1:2009	26°
Static stability downhill
(Min.)	RESNA WC/Vol.1
Section 1:1998	12°	RESNA WC/Vol.1
Section 1:2009	16°
Static stability uphill
(Max.)	RESNA WC/Vol.1
Section 1:1998	NA	RESNA WC/Vol.1
Section 1:2009	16°
Static stability uphill
(Min.)	RESNA WC/Vol.1
Section 1:1998	11°	RESNA WC/Vol.1
Section 1:2009	15°
Static stability sideways
(Max.)	RESNA WC/Vol.1
Section 1:1998	9°	RESNA WC/Vol.1
Section 1:2009	9.5°
Dynamic stability
downhill	RESNA WC/Vol.1
Section 2:1998	10°	RESNA WC/Vol.1
Section 2:2009	6 °
Minimum braking distance
from max speed	RESNA WC/Vol.1
Section 3:1998	1.15m	RESNA WC/Vol.1
Section 3:2009	1.4m
Cruising range	RESNA WC/Vol.1
Section 4:1998	32km	RESNA WC/Vol.1
Section 4:2009	29km
Overall length	RESNA WC/Vol.1
Section 5:1998	1170mm	RESNA WC/Vol.1
Section 5:2009	1210mm
Overall width	RESNA WC/Vol.1
Section 5:1998	560mm	RESNA WC/Vol.1
Section 5:2009	580mm
Folded length	RESNA WC/Vol.1
Section 5:1998	NA	RESNA WC/Vol.1
Section 5:2009	1210mm
Folded width	RESNA WC/Vol.1
Section 5:1998	NA	RESNA WC/Vol.1
Section 5:2009	580mm
Total mass	RESNA WC/Vol.1
Section 5:1998	43kg	RESNA WC/Vol.1
Section 5:2009	85.5kg
Horizontal location of
axle	RESNA WC/Vol.1
Section 5:1998	NA	RESNA WC/Vol.1
Section 5:2009	750mm
Minimum turning radius	RESNA WC/Vol.1
Section 5:1998	1100mm	RESNA WC/Vol.1
Section 5:2009	1400mm
Minimum turn-around
width	RESNA WC/Vol.1
Section 5:1998	1200mm	RESNA WC/Vol.1
Section 5:2009	1600mm
Maximum speed forward	RESNA WC/Vol.1
Section 6:1998	6.4km	RESNA WC/Vol.1
Section 6:2009	9.5km
Seat plane angle (Max.)	RESNA WC/Vol.1
Section 7:1998	0°	RESNA WC/Vol.1
Section 7:2009	5°
Effective seat depth	RESNA WC/Vol.1
Section 7:1998	420mm	RESNA WC/Vol.1
Section 7:2009	430mm
Effective seat width	RESNA WC/Vol.1
Section 7:1998	430mm	RESNA WC/Vol.1
Section 7:2009	460mm
Seat surface height at
front edge (Max.)	RESNA WC/Vol.1
Section 7:1998	NA	RESNA WC/Vol.1
Section 7:2009	620mm
Seat surface height at
front edge (Min.)	RESNA WC/Vol.1
Section 7:1998	500mm	RESNA WC/Vol.1
Section 7:2009	570mm
Backrest angle	RESNA WC/Vol.1
Section 7:1998	10°	RESNA WC/Vol.1
Section 7:2009	10°
Backrest height	RESNA WC/Vol.1
Section 7:1998	360mm	RESNA WC/Vol.1
Section 7:2009	360mm
Obstacle climbing (Max.)	RESNA WC/Vol.1
Section 10:1998	50mm	RESNA WC/Vol.1
Section 10:2009	50mm
Obstacle climbing (Min.)	RESNA WC/Vol.1
Section 10:1998	20mm	RESNA WC/Vol.1
Section 10:2009	15mm
Footrest to seat distance
(Max.)	ISO7176-15:1996	460mm	ISO7176-15:1996	475mm
Footrest to seat distance
(Min.)	ISO7176-15:1996	410mm	ISO7176-15:1996	425mm
Leg to seat surface angle	ISO7176-15:1996	90°	ISO7176-15:1996	90°
Armrest to seat distance	ISO7176-15:1996	210mm	ISO7176-15:1996	210mm
Front location of armrest
structure	ISO7176-15:1996	305mm	ISO7176-15:1996	320mm

11

Image /page/11/Picture/0 description: The image shows a logo with the text "WiU'S Tech" in a stylized font. The letters are red with a green outline, and there are two green dots above the "i" and "U". The word "Tech" is written in a smaller font below the main text. The entire logo is enclosed in a rounded green rectangle.

五氏科技股份有限公司
WU'S TECH CO., LTD

統一編號/70711910 新竹市元培街225號 Telephone/886-3-5382105 FAX /886-3-5382191 No.225 Yuan Peir St. Hsinchu, Taiwan R.O.C. E-MAIL:[e-mail]

● RESNA standards test comparison discussions

1) RESNA WC-1 Section 1

The standard used for testing the static stability of the subject device is RESNA WC-1 Section 1:2009, but the standard used for the predicate device is RESNA WC-1 Section 1:1998. The subject device used updated standard.

The testing results show that the static stability downhill for the subject device is 26 degrees (Max.) / 16 degrees (Min.), the static stability uphill is 16 degrees (Max.) / 15 degrees (Min.) and the static stability sideways is 9.5 degrees. All of the static testing results for the subject device are larger than the predicate device. The differences of the angles show that the subject device has more static stability in three ways than the predicate device. So there are no any new safety and effectiveness concerns raised for the subject device due to the static stability differences.

12

Image /page/12/Picture/0 description: The image shows a logo with the text "Wi's Tech". The text is in red and is surrounded by a green border. The word "Tech" is smaller than the rest of the text and is located at the bottom right of the logo. The logo is simple and clean, with a focus on the text.

新竹市元培街225號 統一編號/70711910 FAX /886-3-5382191 Telephone/886-3-5382105 No.225 Yuan Peir St. Hsinchu, Taiwan R.O.C. E-MAIL:[e-mail]

2) RESNA WC-1 Section 2

The standard used for testing the dynamic stability of the subject device is RESNA WC-1 Section 2:2009, but the standard used for the predicate device is RESNA WC-1 Section 2:1998. The subject device used updated standard.

The dynamic stability downhill is 6 degrees for the subject device and is 10 degrees for the predicate device. AS we knew the Americans with Disabilities Act Accessibility (ADAAG) Section 4.7.2 Slope has regulated that the angle of the slopes that may be encountered in public place and accessible environments that comply with the ADAAG will be required not to have slopes greater than 1:12 (4.8 degrees). The risk level of tip over due to the 4-degree less dynamic stability has been mitigated to an acceptable level by the slope limitation requirements of ADAAG and the disclosure of the dynamic stability information in the user manual. There are no safety and effectiveness concerns raised by the 4-degree less dynamic stability difference for the subject device.

RESNA WC-1 Section 3 3)

The standard used for testing minimum braking distance of the subject device is RESNA WC-1 Section 3:2009, but the standard used for the predicate device is RESNA WC-1 Section 3:1998. The subject device used updated standard.

The minimum braking distance from maximum speed is 1.40 m for subject device and is 1.15 m for predicate device. The subject device needs more 0.25 m distance to stop the wheelchair from the maximum speed than the predicate device. As we knew, the max forward speed for the subject device is 5.9 mph, and it is 4 mph for the predicate device. The higher-speed wheelchair normally needs more braking distance to stop the wheelchair. Since the minimum braking distance information was disclosed in the user manual, the risk level of larger braking distance was reduced to an acceptable level. There are no any safety and effectiveness concerns raised for the subject device due to this braking difference of 0.25 meters.

4) RESNA WC-1 Section 4

The standard used for testing the cruising range of the subject device is RESNA WC-1 Section 4:2009, but the standard used for the predicate device is RESNA WC-1 Section 4:1998. The subject device used updated standard.

13

Image /page/13/Picture/0 description: The image shows a logo with the text "Wi's Tech" in red letters. The letters "Wi's" are larger than the word "Tech", and there are two green dots above the "i" and the "s". The logo is surrounded by a green border.

The cruising range for the subject device is 29 km and it is 32 km for the predicate device. If the user got used to the 29 km cruising range and already knew when the wheelchair needed to be charged, the user would not meet the low-battery situation, which resulted to abnormal driving situation. Thus, based on the above, there are no any new safety and effectiveness concerns raised by this shorter cruising range for the subject device.

ર) RESNA WC-1 Section 5

The standard used for testing the overall dimensions of the subject device is RESNA WC-1 Section 5:2009, but the standard used for the predicate device is RESNA WC-1 Section 5:1998. The subject device used updated standard.

The overall length / width is tested to be 1210 / 580 mm for the subject device and it is 1170 / 560 mm for predicate device. These minor differences mean the subject device is bigger than the predicate device, thus not related to the safety aspects.

The total mass for the subject device is 85.5 kg and it is 43 kg for the predicate device, and the difference comes from bigger sizes of the subject device. The heavier wheelchair will lead to more comfortable feeling and less cruising range. There are no any new safety and effectiveness concerns raised by this difference for the subject device.

The minimum turning radius and minimum turn-around width are 1400 / 1600 mm for the subject device and they are 1100 / 1200 mm for the predicate device. The larger minimum turning radius and minimum turn-around width for the subject device mean that it needs considering more space to make a turn or a turn-around. Since this information was disclosed in the user manual to the users, the risk level of shortage of space was reduced to an acceptable level. There are no any new safety and effectiveness concerns raised by these differences for the subject device.

6) RESNA WC-1 Section 6

The standard used for testing the maximum forward speed of the subject device is RESNA WC-1 Section 6:2009, but the standard used for the predicate device is RESNA WC-1 Section 6:1998. The subject device used updated standard.

14

Image /page/14/Picture/0 description: The image shows a logo with the text "WU'S Tech" in a stylized font. The letters "WU'S" are large and red, with green circles above the "U" and "S". The word "Tech" is smaller and located below the "S" in a different font. The entire logo is enclosed in a green rounded rectangle.

氏科技股份有限公司
U'S TECH CO., LTD

統一編號/70711910 新竹市元培街225號 Telephone/886-3-5382105 FAX /886-3-5382191 No.225 Yuan Peir St. Hsinchu, Taiwan R.O.C. E-MAIL:[e-mail]

The forward speed for the subject device is 5.9 mph and the predicate device is 4 The higher forward speed of the subject device requires more braking mph. distance than the predicate device. The maximum forward speed information was disclosed in the user manual to the users, and the risk level of higher speed was reduced to an acceptable level. There are no any new safety and effectiveness concerns raised by the difference of higher speed for the subject device.

7) RESNA WC-1 Section 7

The standard used for testing the angle and the dimensions of the subject device is RESNA WC-1 Section 7:2009, but the standard used for the predicate device is RESNA WC-1 Section 7:1998. The subject device used updated standard.

The seat plane angle is tested to be 5 degrees for the subject device and it is 0 degree for the predicate device. This difference will result in backward inclination of the user or less happening chance of forward tip-over for the subject device and no any new safety and effectiveness concerns were raised due to the seat plane angle difference for the subject device.

The effective seat depth / effective seat width are tested to be 430 / 460 mm for the subject device and 420 / 430 mm for the predicate device. These differences can result in different comfort feeling during driving period, and they are not related to the safety aspects.

The minimum / maximum seat surface heights at front edge is 570 / 620 mm for the subject device and 500 / 500 mm for the predicate device. The seat surface height of the predicate device is fixed. It means the minimum seat height for the subject device is larger than the predicate device by 70 mm. The seat surface height of the subject device can be adjusted by 50 mm according to the comfortable feeling of users, and it is not related to the safety aspects. There are no any new safety and effectiveness concerns raised by the difference of larger seat surface height for the subject device.

8) RESNA WC-1 Section 10

The standard used for testing the climbing obstacle of the subject device is RESNA WC-1 Section 10:2009, but the standard used for the predicate device is RESNA WC-1 Section 10:1998. The subject device used updated standard.

15

Image /page/15/Picture/0 description: The image shows a logo with the text "WiU'S Tech" in red letters with a green outline. The letters are stylized and have a rounded appearance. The word "Tech" is smaller and located below the "S" in "WiU'S".

科技股份有限公司
TECH CO., LTD
新竹市
Teleph
No.225

統一編號/70711910 新竹市元培街225號 Telephone/886-3-5382105 FAX /886-3-5382191 No.225 Yuan Peir St. Hsinchu, Taiwan R.O.C. E-MAIL:[e-mail]

The maximum / minimum obstacles climbing are 50 / 15 mm for the subject device and 50 / 20 mm for the predicate device. The maximum obstacles climbing are the same and the minimum obstacles are different by 5 mm. The obstacles climbing were disclosed in the user manual and the users will notice the obstacles climbing range, 50 mm to 15 mm, and they are instructed to follow the instructions for use to operate the wheelchair. Thus, there are no any new safety and effectiveness concerns raised due to the minor difference of the climbing obstacle for the subject device.

9) ISO 7176-15

The standard used for testing the relevant distances and angle of the subject device is ISO 7176-15:1996, and the standard used for the predicate device is ISO 7176-15:1996. Both devices used the same standard.

Footrest to seat distances (Max./ Min.) were tested to be 475 /425 mm for subject device and 460 / 410 mm for predicate device. These distances for both devices can be adjusted 50 mm by changing the vertical position of the footrest between the minimum position and maximum position. The users of two devices can adjust the positions of the footrest according to the comfort feeling at various positions. These differences are not related to any safety aspects. There are no any new safety and effectiveness concerns raised due to these differences for the subject device.

Front location of armrest structure is 320 mm for the subject device and is 305 mm for the predicate device. The armrest is intended for use for resting arms, and people's arms have minor differences of lengths, so the front location of armrest structure for the larger overall design of the subject device is 15 mm larger than the predicate device accordingly. It is not related to any safety aspect. There are no any new safety and effectiveness concerns raised by the difference of larger front location of armrest structure for the subject device.

● CONCLUSIONS

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 predicate device, K032489 Wu's Tech WT-M4Jr. identified in the submission. Thus, the subject device is substantially equivalent to the predicate device.