Electric wheelchair (S7204/S7205)

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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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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: {4}------------------------------------------------ #### 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. {5}------------------------------------------------ #### 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 {6}------------------------------------------------ ## 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 of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Company | Dongguan Prestige<br>Sporting Goods Co.,<br>Ltd. | Eurogreen International<br>Inc. | Permobil AB | -- | | Trade Name | Electric wheelchair | "SupaChair" Powered<br>Wheelchair: Safari,<br>Safari Sport, Mini<br>Safari | M300 & M400 | -- | | Model | S7204, S7205 | -- | -- | -- | | Classification<br>Name | Wheelchair, Powered | Wheelchair, Powered | Wheelchair, Powered | SE | | 510K<br>Number | K202632 | K173315 | K123290 | -- | | Product<br>Code | ITI | ITI | ITI | SE | | Common or<br>Usual name | Powered Wheelchair | Powered Wheelchair | Powered Wheelchair | SE | | Intended<br>use/Indications for Use | The device is a power<br>wheelchair intended to<br>provide mobility to<br>persons restricted to a<br>sitting position. | The device is a power<br>wheelchair intended to<br>provide mobility to<br>persons restricted to a<br>sitting position. | The intended use of<br>the M300 & M400<br>powered wheelchair is<br>to provide outdoor and<br>indoor mobility to<br>persons limited to a<br>seated position that<br>are capable of<br>operating a powered<br>wheelchair. | SE | | Size | For model S7204:<br>1000mm x 680mm x<br>1330mm<br>For model S7205:<br>1000mm x 700mm x<br>1340mm | 870mm*600mm*840mm | 1256 mm x 620mm x<br>1260 mm | SE<br>Note 1 | | Overall<br>length | For model S7204:<br>1000mm<br>For model S7205:<br>1000mm | 870mm | 1256 mm | SE<br>Note 1 | | Overall width | For model S7204:<br>680mm<br>For model S7205:<br>700mm | 600mm | 620mm | SE<br>Note 1 | | Total mass | For model S7204:<br>150kg approx.<br>For model S7205:<br>145kg approx. | 37.7kg | 155kg (342 lbs) | SE<br>Note 1 | | Mass of<br>heaviest part | For model S7204:<br>134kg approx.<br>For model S7205:<br>129kg approx. | 17.9kg | Not public | SE<br>Note 1 | | Effective seat<br>depth | 480mm | 400mm | Not public | SE<br>Note 1 | | Effective seat<br>width | 520mm | 410mm | Not public | SE<br>Note 1 | | Back support<br>height | 810mm | 370mm | Not public | SE<br>Note 1 | | Front of arm<br>support to<br>back support | 250mm | 200mm | Not public | SE<br>Note 1 | | Minimum<br>turning<br>diameter | 1200mm | 700mm | Not public | SE<br>Note 1 | | Tires | 6" for front wheel<br>(solid wheel)<br>14" for middle wheel<br>(solid wheel)<br>6" for rear wheel (solid<br>wheel) | Drive wheels size:<br>200mm (8")<br>Caster wheels size:<br>178mm (7") | Caster wheel: 200x50<br>mm<br>Drive wheel: 3.00-8" | SE<br>Note 1 | | Speed | 7km/h(4.3mph) | 6.5kph (4mph) | Up to 12 km/h (7,5<br>mph) | SE<br>Note 2 | | Safe<br>Gradient /<br>Maximum<br>Gradient | 10° | 9° | Not public | SE<br>Note 2 | | Range | 45km | SLA: 10km<br>Lithium: 16.5km | Up to 25 km | SE<br>Note 2 | | Turning<br>Radius | 700mm | 700mm | 800mm | SE | | Base weight<br>(not including<br>battery) | For model S7204:<br>134kg approx.<br>For model S7205:<br>129kg approx. | 28.5kg | Not public | SE<br>Note 1 | | Battery<br>weight | 16 kg | SLA: 9.2kg<br>Lithium: 4kg | Not public | SE<br>Note 1 | | Brake | Electromagnetic | Electromagnetic | Electronic braking via<br>drive motors and<br>magnetic | SE | | Drive system | Dynamic | Dynamic | Not public | SE | | Maximum<br>capacity | 136 kg | 150 kg | 136 kg | SE | | Ground<br>clearance | 50mm | 70mm | 77 mm | SE<br>Note 2 | | Minimum<br>Braking Time | 1.54s | Not public | Not public | SE<br>Note 4 | | Minimum<br>Braking<br>Distance | 1.5m | Not public | Not public | SE<br>Note 4 | | Brake<br>distance-<br>Normal<br>operation<br>(Horizontal-<br>Forward-Max<br>speed) | 1.5-1.8m | 1.0-1.5m | Not public | SE<br>Note 4 | | Battery | Li-ion Battery 25.2V<br>30AH*2 | SLA/Lithium: 24V 15Ah | Not public | SE<br>Note 3 | | charger | 24V 15A | SLA: 2A off board<br>Lithium: 4A off board | Not public | SE<br>Note 3 | | Frame<br>design | Rigid frame | Rigid frame | Not public | SE | | Material | Aluminum | Aluminum | Not public | SE | | Biocompatibil<br>ity | All user directly<br>contacting materials<br>are compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | Not public | SE | | Electrical<br>Safety | ISO 7176 series | ISO 7176 series | ISO 7176 series | SE | | EMC | ISO 7176 - 21 | ISO 7176 - 21 | ISO 7176 - 21 | SE | {7}------------------------------------------------ {8}------------------------------------------------ #### 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. {9}------------------------------------------------ #### 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