K Number

Device Name

Electric wheelchair (S7204/S7205)

Manufacturer

Dongguan Prestige Sporting Goods Co., Ltd.

Date Cleared

2021-04-08

(209 days)

Product Code

ITI

Regulation Number

890.3860

Intended Use

The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.

Device Description

The Electric wheelchair (Model S7204, S7205) is a power wheelchair intended to provide mobility to persons restricted to a sitting position. The Electric wheelchair (Model S7204, S7205) is about 136 kg weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a welded-aluminum frames, sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and Li-ion batteries with an off-board battery charger. It is powered by rechargeable batteries with 45 km which maximum speed up to 7 km/h. The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released. the electromagnetic brake will be actuated and the power wheelchair is slow to stop. It consists of three parts which are chair part, control part and drive part. Overall it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, an controller, an electric motor, an electromagnetic brake and a Lithium battery with an off-board charger. The result of "tiltover" tests performed laterally (12° ), posteriorly (16° ), and anteriorly (12° ) with a user of maximum allowable weight in the least stable configuration: No overturn performed laterally, posteriorly, and anteriorly with 136kg in the least stable configuration.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K173315, K123290

Reference Devices

K173315,K123290

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a conventional power wheelchair with standard components and control mechanisms, with no mention of AI or ML.

Therapeutic

Explanation: The device is described as a power wheelchair intended to provide mobility, not to treat or cure a disease or condition, which is the primary function of a therapeutic device.

Diagnostic

The device description explicitly states its purpose is "to provide mobility to persons restricted to a sitting position." There is no mention of it being used to detect, diagnose, monitor, or treat any medical condition; it is solely a mobility aid.

SaMD (Software as a Medical Device)

The device description clearly outlines numerous hardware components including a frame, wheels, motors, batteries, brakes, and a joystick controller. The performance studies also reference standards related to the physical characteristics and safety of wheelchairs, not solely software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Description: The provided description clearly states the device is a "power wheelchair intended to provide mobility to persons restricted to a sitting position." It describes a mechanical and electrical device for transportation and mobility.
Intended Use: The intended use is for mobility, not for testing biological samples.
Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, analyzing, or testing biological samples.

Therefore, based on the provided information, the device is a mobility aid, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.

Product codes

ITI

Device Description

The Electric wheelchair (Model S7204, S7205) is a power wheelchair intended to provide mobility to persons restricted to a sitting position.

The Electric wheelchair (Model S7204, S7205) is about 136 kg weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a welded-aluminum frames, sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and Li-ion batteries with an off-board battery charger. It is powered by rechargeable batteries with 45 km which maximum speed up to 7 km/h. The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released. the electromagnetic brake will be actuated and the power wheelchair is slow to stop.

It consists of three parts which are chair part, control part and drive part. Overall it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, an controller, an electric motor, an electromagnetic brake and a Lithium battery with an off-board charger. The result of "tiltover" tests performed laterally (12° ), posteriorly (16° ), and anteriorly (12° ) with a user of maximum allowable weight in the least stable configuration: No overturn performed laterally, posteriorly, and anteriorly with 136kg in the least stable configuration.

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)

The following performance and safety tests were conducted with Electric wheelchair:

· ISO 7176-1: 2014, Wheelchairs - Part 1: Determination of static stability

• ISO 7176-2: Third edition 2017-10, Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs

• ISO 7176-3: 2012, Wheelchairs - Part 3: Determination of effectiveness of brakes

• ISO 7176-4: Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range

· ISO 7176-5: Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space

• ISO 7176-6: Third edition 2018-06 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs

• ISO 7176-7: First Edition 1998-05-15, Wheelchairs - Part 7: Measurement of seating and wheel dimensions

• ISO 7176-8: 2014, Wheelchairs - Part 8: Requirements and test methods for static, impact and faligue strenaths

· ISO 7176-9: 2009, Wheelchairs - Part 9: Climatic tests for Powered Wheelchairs

• ISO 7176-10: 2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs

• ISO 7176-11: Second edition 2012-12-01. Wheelchairs - Part 11: Test dummies

• ISO 7176-13: First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces

• ISO 7176-14: 2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods

• ISO 7176-15: 1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling

• ISO 7176-16: Second edition 2012-12-01, Wheelchairs - Part 16: Resistance to ignition of postural support devices

• ISO 7176-21: Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and battery chargers

• ISO 7176-22: Second Edition 2014-09-01 Wheelchairs - Part 22: Set-Up Procedures

· IEC 62304: 2006 (First Edition), Medical device software. Software life- cycle processes

• IEC 60601-1-6: Medical electrical equipment- Part1-6: General requirements for safety- Collateral Standard: Usability Edition 3.0, 2010

• IEC 62366 Medical devices – Application of usability engineering to medical devices Edition 1.0, 2007

The materials and manufacturing used for the Electric wheelchair are identical to those of the predicate device K122749, which were demonstrated to conform with the following biocompatibility standards:

• ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity

• ISO 10993-10: 2009, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

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

Not Found

Predicate Device(s)

K173315, K123290

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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

April 8, 2021

Dongguan Prestige Sporting Goods Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 510663 China

Re: K202632

Trade/Device Name: Electric wheelchair, Models: S7204, S7205 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 8, 2021 Received: January 11, 2021

Dear Cassie Lee:

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/cfpm/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, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 53 1 -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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice ( 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 (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Heather L. Dean -S

Heather Dean, PhD Assistant Director. Acute Injurv Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Indications for Use

510(k) Number (if known) K202632

Device Name Electric wheelchair, Models: S7204, S7205

Indications for Use (Describe)

The device is a power wheelchair intended 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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510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

� 510(k) Owner's Name: Dongguan Prestige Sporting Goods Co., Ltd
Establishment Registration Number: 3008841035 �
� Address: 3rd industrial, Qiaotou Area, Houjie Town, Dongguan City, Guangdong province, China, 523950
� Tel: 13763128800
� Fax: 86-769-85922505
Contact Person: Zhang Zhao (General Manager) �
� E-mail: leon@solaxtech.com

Application Correspondent:

Contact Person: Ms. Cassie Lee �
� Guangzhou GLOMED Biological Technology Co., Ltd.
� Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China
� Tel: +86 20 8266 2446
� Email: regulatory@glomed-info.com

2. Subject Device Information

� Trade Name: Electric wheelchair, Model: S7204, S7205
Powered Wheelchair Common Name: �
Wheelchair, Powered Classification name: �
Physical Medicine Device Review Panel: �
ITI Product Code: �
ll Regulation Class: �
890.3860 � Regulation Number:

3. Predicate Device Information

� Sponsor: Eurogreen International Inc.
� Device Trade name: "SupaChair" Powered Wheelchair: Safari, Safari Sport, Mini
Common name: Powered Wheelchair �
� Classification name: Wheelchair, Powered
� 510K Number: K173315
� Medical specialty (Panel): Physical Medicine Device
Requlation number: 890,3860 �
Product Code: ITI �
� Classification: Class II

Predicate Device 2

Sponsor: Permobil AB �
� Device Trade name: M300 & M400
� Common name: Powered Wheelchair
� Classification name: Wheelchair, Powered
510K Number: K123290 �
Medical specialty (Panel): Physical Medicine Device �
� Regulation number: 890.3860
� Product Code: ITI
� Classification: Class II

Device Description ব

The Electric wheelchair (Model S7204, S7205) is a power wheelchair intended to provide mobility to persons restricted to a sitting position.

5. Intended Use / Indications for Use

The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position

6. Tests Summary