(260 days)
The Electric wheelchair is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.
The Electric wheelchair (Model S7012) is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair. The device and accessories (remote controller, AC power wire, charger, and battery) are reusable. The Electric wheelchair (Model S7012) is about 125 kg weight capacity and size is about 840mm x 640mm x 930mm if unfold and about 700mm x 640mm x 370mm if fold. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable 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 has some components as two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, and has a remote for folding/unfolding the device. Its basic function is powered by rechargeable batteries with 15 km which has a maximum speed up to 6 km/h. The controller with a joystick attaches to either armrest 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. The joystick can move up and down, left and right. There is a speed button to adjust the speed, and the speed indicator can display the speed. In addition, there is a remote control to control the folding and unfolding of the device. And no any new features of the device.
The provided text is a 510(k) Summary for an Electric Wheelchair (Model: S7012). It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical studies against acceptance criteria in the manner one might expect for a novel AI/software as a medical device.
Therefore, the requested information regarding detailed acceptance criteria, study design for proving those criteria, sample size for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment does not apply in the context of this traditional medical device submission. The submission relies on adherence to established international standards for wheelchairs and a comparison of technical specifications to a predicate device.
However, I can extract the closest analogous information from the document:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are generally implied by conformity to the listed ISO and IEC standards and demonstrating substantial equivalence to the predicate device in terms of specifications. The "reported device performance" is given by the subject device's specifications.
| Element of Comparison | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Subject Device) | Notes for Equivalence |
|---|---|---|---|
| General | Conformity to ISO 7176 series, IEC 62304, IEC 60601-1-6, IEC 62366, ISO 10993 series | Complies with all listed standards | Explicitly stated that the device complies with these standards. |
| Intended Use | Provide mobility to a disabled or elderly person limited to a seated position. | Provide mobility to a disabled or elderly limited to a seated position. | Substantially Equivalent (SE). The intent is the same. |
| Dimensions (e.g., Unfold Size) | Similar to predicate (e.g., 890 mm *603 mm *670 mm approx) | 840mm x 640mm x 930mm | SE: "subtle changes of the physical characteristics will not affect the critical functions or the normal use." (Note 1) |
| Total Mass | Similar to predicate (e.g., 28 kg) | 25.84 kg | SE: "subtle changes of the physical characteristics will not affect the critical functions or the normal use." (Note 1) |
| Speed | Similar to predicate (e.g., 7 km/h) | 6 km/h | SE: "very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use." (Note 2) |
| Safe Gradient | Similar to predicate (e.g., 0-12°) | 0-8° | SE: "very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use." (Note 2) |
| Range | Similar to predicate (e.g., 20 km) | 16 km | SE: "very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use." (Note 2) |
| Maximum Capacity | Similar to predicate (e.g., 100 kg) | 125 kg | SE: "very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use." (Note 2) |
| Obstacle Climbing Ability | Similar to predicate (e.g., 25 mm) | 40 mm | SE: "very similar and all also comply with ISO 7176 series standards requirements, it will not affect the main function and the intended use." (Note 2) |
| Battery | Similar to predicate (e.g., Lithium 24V/20AH) | Lithium battery 24V/10Ah | SE: "both of them are comply with the standards IEC 62133 and ISO 7176, it will not raise any safety or effectiveness issue." (Note 3) |
| Motor | Similar to predicate (e.g., 24V 250W) | 24V 137W | SE: "both of them are comply with the standards IEC 62133 and ISO 7176, it will not raise any safety or effectiveness issue." (Note 3) |
| Brake | Electromagnetic | Electromagnetic | SE |
| Biocompatibility | Compliance with ISO10993-5 and ISO10993-10 | Compliance with ISO10993-5 and ISO10993-10 | SE. |
| Electrical Safety / EMC | Compliance with ISO 7176 series / ISO 7176-21 | Compliance with ISO 7176 series / ISO 7176-21 | SE. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The "tests" mentioned are conformity to international standards (e.g., ISO 7176 series, IEC 62304) for a physical device, not statistical performance evaluations against a test set of data. These standards typically involve testing a single or a small number of physical units to verify specifications and safety features.
- Data Provenance: Not applicable in the context of data used for statistical evaluation of a test set. The provenance of the tested device itself is Dongguan Prestige Sporting Goods Co., Ltd., China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. This device is an electric wheelchair, not an AI/diagnostic device that generates an output needing expert "ground truth." The "truth" is established by direct physical measurement, engineering tests, and adherence to performance specifications outlined in the international standards cited (e.g., measuring speed, stability, brake effectiveness).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for this type of device submission. Adjudication methods are typically used in clinical studies where expert consensus is needed to define a ground truth for a diagnostic outcome.
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. MRMC studies are specific to evaluating the effectiveness of AI-assisted diagnostic tools on human reader performance. This device is a physical mobility aid.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product (electric wheelchair), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance relies on:
- Direct Physical Measurements: E.g., dimensions, weight, speed, range, turning radius.
- Engineered Safety Standards: Compliance with ISO 7176 series (static stability, dynamic stability, brakes, strength, climatic tests, EMC, etc.), IEC 62304 (software life-cycle), IEC 60601-1-6 (usability), IEC 62366 (usability engineering), and ISO 10993 series (biocompatibility).
- Comparison to a Predicate Device: Demonstrating that any differences in specifications do not raise new questions of safety or effectiveness.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
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December 17, 2020
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: K200857
Trade/Device Name: Electric wheelchair (Model: S7012) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 27, 2020 Received: October 1, 2020
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/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, 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 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). Addtionally, 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, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200857
Device Name Electric wheelchair (Model: S7012)
Indications for Use (Describe)
The Electric wheelchair is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated 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 K200857
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
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2. Subject Device Information
| Trade Name: | Electric wheelchair (Model: S7012) |
|---|---|
| Common Name: | Powered Wheelchair |
| Classification name: | Wheelchair, Powered |
| Review Panel: | Physical Medicine Device |
| Product Code: | ITI |
| Regulation Class: | 2 |
| Regulation Number: | 890.3860 |
3. Predicate Device Information
Sponsor: Kunshan Aoshida Electric Technology Co., Ltd.
Device Trade name: A08 powered Wheelchair
Common name: Powered Wheelchair
Classification name: Wheelchair, Powered
510K Number: K163204
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3860
Product Code: ITI
Classification: Class 2
4. Device Description
The Electric wheelchair (Model S7012) is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair. The
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device and accessories (remote controller, AC power wire, charger, and battery) are reusable. The Electric wheelchair (Model S7012) is about 125 kg weight capacity and size is about 840mm x 640mm x 930mm if unfold and about 700mm x 640mm x 370mm if fold. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable 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 has some components as two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, and has a remote for folding/unfolding the device.
lts basic function is powered by rechargeable batteries with 15 km which has a maximum speed up to 6 km/h. The controller with a joystick attaches to either armrest 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. The joystick can move up and down, left and right. There is a speed button to adjust the speed, and the speed indicator can display the speed. In addition, there is a remote control to control the folding and unfolding of the device. And no any new features of the device.
5. Intended Use / Indications for Use
The Electric wheelchair is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated 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 7176-2:2001, Wheelchairs Part 2: Determination of dynamic stability of Powered
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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 maneuvering space -
· ISO 7176-6: 2001, Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of Powered 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 fatigue strengths
• 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 Electric 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 Electric 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
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postural support devices
· ISO 7176-21 Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of Electric 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 reference 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
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.
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The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Company | Dongguan Prestige SportingGoods Co., Ltd. | Kunshan Aoshida ElectricTechnology Co., Ltd. | -- |
| Trade Name | Electric wheelchair (ModelS7012) | A08 power wheelchair | -- |
| ClassificationName | Wheelchair, Powered | Wheelchair, Powered | SE |
| 510K Number | K200857 | K163204 | -- |
| Product Code | ITI | ITI | SE |
| Common orUsual name | Powered Wheelchair | Powered Wheelchair | SE |
| Intended use/Indications forUse | The Electric wheelchair is amotor driven transportationvehicle with the intended useto provide mobility to adisabled or elderly limited to aseated position. | This device is a motordriven, indoor and outdoortransportation vehicle withthe intended use to providemobility to a disabled orelderly person limited to aseated position. | SE |
| Size (unfold) | 840mm x 640mm x 930mm | 890 mm *603 mm *670 mm | SENote 1 |
| Overall length | 840mm | 890 mm (35") | SE |
| Note 1 | |||
| Overall width | 640mm | 603 mm (23.7") | SE |
| Note 1 | |||
| Stowage length | 700mm | 324 mm (12.8") | SE |
| Note 1 | |||
| Stowage width | 640mm | 603 mm (23.7") | SE |
| Note 1 | |||
| Stowage height | 370mm | 670 mm (26.4") | SE |
| Note 1 | |||
| Total mass | 25.84 kg | 28 kg (61.7 lbs) | SE |
| Note 1 | |||
| Mass of heaviest part | 24kg | 24 kg (53 lbs) | SE |
| Seat plane angle | 5° | 2 ° | SE |
| Note 1 | |||
| Effective seat depth | 430mm | 430 mm (17") | SE |
| Effective seat width | 430mm | 450 mm (17.7") | SE |
| Note 1 | |||
| Seat surface height at front edge | 520mm | 470 mm (18.5") | SE |
| Note 1 | |||
| Back supportangle | $10^\circ$ or $18^\circ$ | $20^\circ$ | SENote 1 |
| Back supportheight | 450mm | 470 mm (18.5") | SENote 1 |
| Foot supportto seatdistance | 410mm | 400 mm (15.7") | SENote 1 |
| Arm supportheight | 225mm | 200 mm (7.9") | SENote 1 |
| Front of armsupport toback support | 315mm | 350 mm (13.8") | SENote 1 |
| Minimumturningdiameter | 1550mm | 1600 mm | SENote 1 |
| Tires | 6 inches for front wheel (solid wheel)7 inches for rear wheel (solid wheel) | 7" x 2"inches for front wheel (solid wheel)10" x 2.35" for rear wheel (solid wheel) | SENote 1 |
| Speed | 6 km/h (3.7mph) | 7 km/h (4.4mph) | SENote 2 |
| Safe Gradient / Maximum | 0-8° | 0-12° | SENote 2 |
| Gradient | |||
| Range | 16 km (9.32mile) | 20 km (12.43mile) | SENote 2 |
| TurningRadius | 0.73 m | 0.8 m | SENote 2 |
| Base weight(not includingbattery) | 24 kg approx. | 24.0 kg | SE |
| Battery weight | 1.84 kg | 4.00kg | SENote 1 |
| Brake | Electromagnetic | Electromagnetic | SE |
| Drive system | PG 45A / Rear wheel drive | PG 45A / Rear wheel drive | SE |
| Maximumcapacity | 125 kg | 100 kg | SENote 2 |
| Groundclearance | 100 mm | 63.5 mm | SENote 2 |
| ObstacleClimbingAbility | 40 mm | 25 mm | SENote 2 |
| Battery | Lithium battery 24V/10Ah | Lithium battery 24V/20AH | SENote 3 |
| Motor | 24V 137W | 24V 250W | SENote 3 |
| Batterycharger | DC 24V/2A | DC24V/2A | SE |
| Frame design | Rigid frame | Rigid frame | SE |
| Foldingmechanism | X type | Inverted Y-type | SENote 4 |
| Material | Aluminum | Aluminum | SE |
| Remotecontrol | Yes | Yes | SE |
| Biocompatibility | All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements. | All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10requirements. | SE |
| ElectricalSafety | ISO 7176 series | ISO 7176 series | SE |
| EMC | ISO 7176 - 21 | ISO 7176 - 21 | SE |
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Comparison in Detail(s):
Note 1:
Although "Size", "Overall length", "Overall width", "Stowage width", "Stowage width", "Stowage height", "Total mass", "Seat plane angle", "Effective seat width", "Seat surface height at front edge", "Back support angle", "Back support height", "Foot support to seat distance", "Arm support height",
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"Front of arm support to back support", "Minimum turning diameter", "Tires" 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", " Turning Radius", "Maximum capacity", " Ground clearance" and "Obstacle Climbing Ability" 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" and "Motor" of the subject device are a little different from the predicate device, but both of them are comply with the standards IEC 62133 and ISO 7176, it will not raise any safety or effectiveness issue.
Note 4:
Although the "Folding mechanism" of the subject device are a little different from the predicate device, but both of them are comply with the standards ISO 7176, it will not raise any safety or effectiveness issue.
Final Conclusion:
The subject device Electric wheelchair (Model: S7012) is Substantially Equivalent to the predicate devices.
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8. Date of the summary prepared
December 15, 2020
§ 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).