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.

AI/ML Overview

The provided text is a 510(k) summary for an Electric Wheelchair, Models: S7204, S7205. It describes the device, its intended use, and comparative testing against predicate devices to establish substantial equivalence.

However, the document does not describe an AI medical device or a study involving human readers or AI assistance. It focuses on the physical and functional characteristics of an electric wheelchair and its compliance with various ISO and IEC standards relevant to wheelchairs and medical electrical equipment.

Therefore, many of the requested criteria cannot be extracted from this document, as they pertain to AI/ML device performance and clinical studies involving expert readers, which are not present here.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance Study (Electric Wheelchair)

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a typical table format for an AI device. Instead, it refers to compliance with various international standards for wheelchairs and medical electrical equipment. The "reported device performance" is mainly a comparison of the subject device's specifications against those of two predicate devices, with notations on substantial equivalence.

Key Performance & Safety Standards (implicit acceptance criteria by compliance):

Standard	Purpose/Criteria	Device Performance / Compliance
ISO 7176-1: 2014	Static stability	Performed. No overturn performed laterally (12°), posteriorly (16°), and anteriorly (12°) with 136kg in the least stable configuration. (Also mentioned in Device Description)
ISO 7176-2: 2017-10	Dynamic stability	Compliant (implied by inclusion in "Tests Summary" and overall SE conclusion)
ISO 7176-3: 2012	Effectiveness of brakes	Compliant. Minimum Braking Time: 1.54s, Minimum Braking Distance: 1.5m, Brake distance-Normal operation (Horizontal-Forward-Max speed): 1.5-1.8m. These values, though different from predicate, still comply with ISO 7176-3.
ISO 7176-4: 2008-10-01	Energy consumption & theoretical distance range	Range: 45km. Compliant with standard requirements (implied by inclusion in "Tests Summary" and Note 2 stating compliance with ISO 7176 series standards).
ISO 7176-5: 2008-06-01	Overall dimensions, mass & maneuvering space	Compliant. Various dimensions and masses are provided for models S7204/S7205 (e.g., Size, Overall length, Overall width, Total mass, Mass of heaviest part, Minimum turning diameter). Differences from predicates are noted but deemed not to raise safety/effectiveness issues as they are "mechanical parameters" and "very similar."
ISO 7176-6: 2018-06	Maximum speed, acceleration & deceleration	Compliant. Speed: 7km/h (4.3mph). Differences from predicates are noted but deemed not to raise safety/effectiveness issues as they comply with ISO 7176 series standards.
ISO 7176-7: 1998-05-15	Seating and wheel dimensions	Compliant. Effective seat depth: 480mm, Effective seat width: 520mm, Back support height: 810mm, Front of arm support to back support: 250mm, Tires: 6" front, 14" middle, 6" rear (solid wheels). Differences from predicates are noted but deemed not to raise safety/effectiveness issues as they are "mechanical parameters" and "very similar."
ISO 7176-8: 2014	Static, impact and fatigue strengths	Compliant (implied by inclusion in "Tests Summary")
ISO 7176-9: 2009	Climatic tests	Compliant (implied by inclusion in "Tests Summary")
ISO 7176-10: 2008	Obstacle-climbing ability	Safe Gradient / Maximum Gradient: 10°. Compliant with standard requirements (implied by inclusion in "Tests Summary" and Note 2 stating compliance with ISO 7176 series standards).
ISO 7176-11: 2012-12-01	Test dummies	Used in testing (implied by inclusion in "Tests Summary")
ISO 7176-13: 1989-08-01	Coefficient of friction of test surfaces	Used in testing (implied by inclusion in "Tests Summary")
ISO 7176-14: 2008	Power and control systems	Compliant (implied by inclusion in "Tests Summary")
ISO 7176-15: 1996	Information disclosure, documentation and labeling	Compliant (implied by inclusion in "Tests Summary")
ISO 7176-16: 2012-12-01	Resistance to ignition of postural support devices	Compliant (implied by inclusion in "Tests Summary")
ISO 7176-21: 2009-04-01	Electromagnetic compatibility (EMC)	Compliant ("EMC" row in comparison table explicitly states "ISO 7176 - 21")
ISO 10993-5:2009 & ISO 10993-10: 2009	Biocompatibility (In Vitro cytotoxicity, Irritation & delayed-type hypersensitivity)	All user directly contacting materials are compliant with ISO10993-5 and ISO10993-10 requirements.
IEC 62304: 2006	Medical device software life-cycle processes	Not applicable for a non-software/AI medical device submission where software is not the primary mechanism of action or being evaluated as an AI. It's likely general software development for embedded control.
IEC 60601-1-6: 2010 & IEC 62366: 2007	Usability engineering	Compliant (implied by inclusion in "Tests Summary"). These apply to the device's operational interface and safety for the user.
Maximum capacity	Weight capacity	136 kg. Substantially Equivalent to predicate devices (one had 150 kg, the other 136 kg).

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

Not applicable. The "test set" here refers to the device itself and components undergoing engineering and safety tests, not a dataset for an AI model. Testing was performed on the electric wheelchair models S7204 and S7205. The provenance of the data is from specific tests conducted by the manufacturer/laboratories against established international standards.

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

Not applicable. This is not an AI/ML device requiring expert ground truth for a diagnostic or prognostic task. The "ground truth" is established by the specifications defined in the international standards (e.g., how to measure static stability, speed, brake performance).

4. Adjudication method for the test set

Not applicable. This concept typically applies to expert review of data for AI model training or evaluation, which is not relevant here. The evaluation is based on compliance of physical and functional tests with established standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an electric wheelchair, not an AI-assisted diagnostic or prognostic device. No MRMC study or evaluation of human readers with/without AI assistance was performed.

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

Not applicable. This is an electric wheelchair. There is no standalone algorithm being evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" is defined by the objective performance criteria and methodologies outlined in the referenced ISO and IEC standards. For example, static stability is measured according to ISO 7176-1, brake performance according to ISO 7176-3, and biocompatibility according to ISO 10993. These are engineering and safety standards, not clinical ground truth of a diagnostic nature.

8. The sample size for the training set

Not applicable. This is not an AI/ML device relying on a training set.

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

Not applicable. This is not an AI/ML device.

Summary

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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.

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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

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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:

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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.

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.

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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

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

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7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Electric wheelchair is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
Company	Dongguan PrestigeSporting Goods Co.,Ltd.	Eurogreen InternationalInc.	Permobil AB	--
Trade Name	Electric wheelchair	"SupaChair" PoweredWheelchair: Safari,Safari Sport, MiniSafari	M300 & M400	--
Model	S7204, S7205	--	--	--
ClassificationName	Wheelchair, Powered	Wheelchair, Powered	Wheelchair, Powered	SE
510KNumber	K202632	K173315	K123290	--
ProductCode	ITI	ITI	ITI	SE
Common orUsual name	Powered Wheelchair	Powered Wheelchair	Powered Wheelchair	SE
Intendeduse/Indications for Use	The device is a powerwheelchair intended toprovide mobility topersons restricted to asitting position.	The device is a powerwheelchair intended toprovide mobility topersons restricted to asitting position.	The intended use ofthe M300 & M400powered wheelchair isto provide outdoor andindoor mobility topersons limited to aseated position thatare capable ofoperating a poweredwheelchair.	SE
Size	For model S7204:1000mm x 680mm x1330mmFor model S7205:1000mm x 700mm x1340mm	870mm600mm840mm	1256 mm x 620mm x1260 mm	SENote 1
Overalllength	For model S7204:1000mmFor model S7205:1000mm	870mm	1256 mm	SENote 1
Overall width	For model S7204:680mmFor model S7205:700mm	600mm	620mm	SENote 1
Total mass	For model S7204:150kg approx.For model S7205:145kg approx.	37.7kg	155kg (342 lbs)	SENote 1
Mass ofheaviest part	For model S7204:134kg approx.For model S7205:129kg approx.	17.9kg	Not public	SENote 1
Effective seatdepth	480mm	400mm	Not public	SENote 1
Effective seatwidth	520mm	410mm	Not public	SENote 1
Back supportheight	810mm	370mm	Not public	SENote 1
Front of armsupport toback support	250mm	200mm	Not public	SENote 1
Minimumturningdiameter	1200mm	700mm	Not public	SENote 1
Tires	6" for front wheel(solid wheel)14" for middle wheel(solid wheel)6" for rear wheel (solidwheel)	Drive wheels size:200mm (8")Caster wheels size:178mm (7")	Caster wheel: 200x50mmDrive wheel: 3.00-8"	SENote 1
Speed	7km/h(4.3mph)	6.5kph (4mph)	Up to 12 km/h (7,5mph)	SENote 2
SafeGradient /MaximumGradient	10°	9°	Not public	SENote 2
Range	45km	SLA: 10kmLithium: 16.5km	Up to 25 km	SENote 2
TurningRadius	700mm	700mm	800mm	SE
Base weight(not includingbattery)	For model S7204:134kg approx.For model S7205:129kg approx.	28.5kg	Not public	SENote 1
Batteryweight	16 kg	SLA: 9.2kgLithium: 4kg	Not public	SENote 1
Brake	Electromagnetic	Electromagnetic	Electronic braking viadrive motors andmagnetic	SE
Drive system	Dynamic	Dynamic	Not public	SE
Maximumcapacity	136 kg	150 kg	136 kg	SE
Groundclearance	50mm	70mm	77 mm	SENote 2
MinimumBraking Time	1.54s	Not public	Not public	SENote 4
MinimumBrakingDistance	1.5m	Not public	Not public	SENote 4
Brakedistance-Normaloperation(Horizontal-Forward-Maxspeed)	1.5-1.8m	1.0-1.5m	Not public	SENote 4
Battery	Li-ion Battery 25.2V30AH*2	SLA/Lithium: 24V 15Ah	Not public	SENote 3
charger	24V 15A	SLA: 2A off boardLithium: 4A off board	Not public	SENote 3
Framedesign	Rigid frame	Rigid frame	Not public	SE
Material	Aluminum	Aluminum	Not public	SE
Biocompatibility	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	Not public	SE
ElectricalSafety	ISO 7176 series	ISO 7176 series	ISO 7176 series	SE
EMC	ISO 7176 - 21	ISO 7176 - 21	ISO 7176 - 21	SE

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Comparison in Detail(s):

Note 1:

Although "Size", "Overall width", "Stowage length", "Stowage width", "Stowage height", "Mass of heaviest part" "Total mass", "Effective seat width", "Back support height", "Effective seat depth", "Minimum turning diameter", "Tires", "Base weight", "Front of arm support to back support" and "Battery weight" which are parameters required in ISO 7176-5 and ISO 7176-7 of the subject device are different from the predicate devices, however, these are some mechanical parameters, and they are very similar, Besides, the subtle changes of the physical characteristics will not affect the critical functions or the normal use, so these parameters' differences will not raise any safety or effectiveness issue.

Note 2:

Although the "Speed", " Safe Gradient / Maximum Gradient", " Range", " Ground clearance" of the subject device are different from the predicate device, as they very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use of the device, so these parameters' differences will not raise any safety or effectiveness issue.

Note 3:

Although the "Battery", "Charger" of the subject device are a little different from the predicate device, but both of them are comply with the standards IEC 62133, it will not raise any safety or effectiveness issue.

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Note 4:

Although the "Minimum Braking Time", "Minimum Braking Distance" and "Brake distance-Normal operation (Horizontal-Forward-Max speed)" of the subject device are a little different from the predicate device, but both of them are comply with the standards ISO 7176-3, it will not raise any safety or effectiveness issue.

Final Conclusion:

The subject device Electric wheelchair (Model: S7204, S7205) is Substantial Equivalent to the predicate devices K173315 and K123290.

8. Date of the summary prepared

March 11, 2021

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).