(202 days)
The Y207 Electric Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. This product is suitabled people with mobility difficulties and elderly people people.
This electric wheelchair is a motor driven, indoor and outdoor transportation vehicle, which is a device for assisting elderly and disabled people to be mobile. It is suitable for disabled people with mobility difficulties and elderly people.
The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, battery box, controller and charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back upholstery.
The device is powered by Li-ion Battery pack (24V 20Ah, 480Wh) with 20 Km (12.5 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.
The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic intelligent electromagnetic brake system starts to work. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
The provided document is a 510(k) Pre-market Notification for a medical device (Y207 Electric Wheelchair). It details a comparison between the subject device and a predicate device (PL00I power wheelchair). However, it does not contain information about a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance study with defined acceptance criteria for metrics like sensitivity, specificity, accuracy, etc. that would be applicable to an AI/ML powered device.
Instead, the provided text describes the device's adherence to various international standards for wheelchairs (ISO, IEC) and biocompatibility standards, and validates substantial equivalence to a predicate device.
Therefore, the following points address the questions based on the information available in the document, acknowledging that typical "acceptance criteria" and "study" as implied by the prompt (which often refers to AI/ML device performance) are not directly applicable here for this type of device submission.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, etc.) for the overall device. Instead, it refers to compliance with numerous international standards for electric wheelchairs and biocompatibility. The reported "performance" is the device's compliance with these standards, ensuring it functions safely and effectively as a powered wheelchair.
Here's a summary of the standards cited for compliance:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 7176-1:2014 (Static stability) | Complied |
| ISO 7176-2:2017 (Dynamic stability of electric wheelchairs) | Complied |
| ISO 7176-3:2012 (Effectiveness of brakes) | Complied (Braking distance ≤1.5m reported in comparison table, but compliance with standard is the primary claim) |
| ISO 7176-4:2008 (Energy consumption/theoretical distance range) | Complied (20 km range reported in comparison table) |
| ISO 7176-5:2008 (Dimensions, mass, maneuvering space) | Complied |
| ISO 7176-6:2001 (Max speed, acceleration, deceleration) | Complied (Max speed forward 0-1.5m/s, Max speed backward 0.8m/s reported in comparison table) |
| ISO 7176-7:1998 (Seating and wheel dimensions) | Complied |
| ISO 7176-8:2014 (Static, impact, and fatigue strength) | Complied |
| ISO 7176-9:2009 (Climatic tests) | Complied |
| ISO 7176-10:2008 (Obstacle-climbing ability) | Complied (Max obstacle climbing 50mm reported in comparison table) |
| ISO 7176-11:2012 (Test dummies) | Complied |
| ISO 7176-13:1989 (Coefficient of friction of test surfaces) | Complied |
| ISO 7176-14:2008 (Power and control systems) | Complied (Software validation carried out) |
| ISO 7176-15:1996 (Information disclosure, documentation, labeling) | Complied |
| ISO 7176-16:2012 (Resistance to ignition of postural support devices) | Complied (Flame retardant test carried out) |
| ISO 7176-21:2009 (Electromagnetic compatibility) | Complied |
| ISO 7176-25:2013 (Batteries and chargers) | Complied |
| IEC 60601-1:2005+A1:2012 (Electrical safety) | Complied |
| IEC 60601-1-2:2014 (Electromagnetic compatibility) | Complied |
| IEC 62133-2:2017 (Safety for Li-ion batteries) | Complied |
| ISO 14971:2007 (Risk Analysis) | Developed in accordance |
| ISO 10993-1:2018 (Biocompatibility) | Complied |
| ISO 10993-5:2009 (Cytotoxicity) | Complied (Specific components passed) |
| ISO 10993-10:2010 (Sensitization, Irritation) | Complied (Specific components passed) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical (bench) testing against international performance standards for wheelchairs. There is no "test set" in the context of patient data or algorithm performance. The testing would involve physical units of the device.
- Sample size: Not specified, but typically this would involve a limited number of physical devices (e.g., one or more production units) undergoing the tests outlined in each standard.
- Data provenance: Not explicitly stated, but the testing would have been conducted by the manufacturer (Jiangsu Intco Medical Products Co., Ltd.) or a contracted testing facility in China, as the manufacturer is based in China. The testing is prospective in the sense that the device was specifically manufactured and then subjected to these standard tests.
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)
This question is not applicable. The approval is for a physical medical device (electric wheelchair), not an AI/ML algorithm that requires expert ground truth labeling. Compliance with engineering and safety standards is assessed through objective measurements and validated test procedures defined within those standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. There is no "adjudication method" in the context of expert review for a physical device's compliance with engineering and safety standards. The results of the tests are objective measurements against specified thresholds in the 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
This question is not applicable. The device is an electric wheelchair, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is an electric wheelchair, not an algorithm. Its "standalone performance" refers to its ability to meet the physical and electrical safety standards as designed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" used for this device approval is the adherence to established international engineering, safety, electrical, and biocompatibility standards (e.g., ISO 7176 series, IEC 60601 series, ISO 10993 series). Success is determined by meeting the specified thresholds and methodologies within these recognized standards.
8. The sample size for the training set
This question is not applicable. There is no "training set" for physical medical devices like an electric wheelchair. The design and manufacturing process involves engineering principles and material selection rather than machine learning training.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
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March 18, 2021
Jiangsu Intco Medical Products Co., Ltd. % Ivv Wang Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, No.1500, Century Ave., Pudong New District Shanghai, Shanghai 200122 China
Re: K202482
Trade/Device Name: Y207 Electric Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 23, 2021 Received: February 25, 2021
Dear Ivy Wang:
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/cfpmr/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-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather Dean, PhD 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) K202482
Device Name Y207 Electric Wheelchair
Indications for Use (Describe)
The Y207 Electric Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. This product is suitabled people with mobility difficulties and elderly people people.
| 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
Date of summary prepared: 2021/03/18
l. SUBMITTER
Name: JIANGSU INTCO MEDICAL PRODUCTS CO., LTD
Address: No.77, Yandunshan Road, Dagang, Zhenjiang, Jiangsu Province 212132, China
Name of contact person: Wang Maokun
Telephone: 0086-511-83174088
Fax: 0086-511-83174188
Device II.
Device trade name: Y207 Electric Wheelchair Classification name: Powered wheelchair Regulation class: 2 Regulation number: 21CFR 890.3860 Panel: Physical Medicine Product code: ITI
III. Predicate device
K113463, PL00I power wheelchair SUZHOU KID MEDICAL APPLIANCE CO., LTD.
IV. Device description
This electric wheelchair is a motor driven, indoor and outdoor transportation vehicle, which is a device for assisting elderly and disabled people to be mobile. It is suitable for disabled people with mobility difficulties and elderly people.
The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, battery box, controller and charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back upholstery.
The device is powered by Li-ion Battery pack (24V 20Ah, 480Wh) with 20 Km (12.5 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.
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The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic intelligent electromagnetic brake system starts to work. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
V. Indication for use
The Y207 Electric Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. This product is suitable for disabled people with mobility difficulties and elderly people.
VI. Comparison of technological characteristics with the predicate device
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Manufacturer | JIANGSU INTCO MEDICALPRODUCTS CO., LTD | SUZHOU KD MedicalAppliance Co. Ltd. | / |
| Proprietary name,model | Electric Wheelchair, Y207 | power wheelchair, PLO00I | / |
| 510(k) number | K202482 | K113463 | / |
| Deviceclassification name | Class II | Class II | Same |
| Classificationregulations | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | Same |
| Similarities | |||
| Indication for use | The Y207 ElectricWheelchair is a motor driven,indoor and outdoortransportation vehicle with theintended use to providemobility to a disabled orelderly person limited to aseated position. This productis suitable for disabled peoplewith mobility difficulties andelderly people. | The device is a motor driven,indoor and outdoortransportation vehicle with theintended use to providemobility to a disabled or elderlyperson limited to a seatedposition. | Same |
| Intended user | disabled people with mobilitydifficulties and elderly people | disabled or elderly personlimited to a seated position | Same |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two front wheelsand two rear wheels | 4, including two pivotingcasters and two rear drive | Same |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| wheels | |||
| Function of wheels | Front wheels: driven wheelssuitable for rotation,acceleration, retrogradeRear wheels: driving wheelsto control the speed anddirection | two pivoting casters: drivenwheels suitable for rotation,acceleration, retrogradetwo rear drive wheels: drivingwheels to control the speedand direction | Same |
| Movement controlmethod | By Joystick control | By Joystick control | Same |
| Driving system | Direct drive on the rearwheels | Direct drive on the rear wheels | Same |
| Brake system | Automatic intelligentelectromagnetic brake system | Intelligent regenerativeElectromagnetic brake | Same |
| Braking distance | ≤1.5 m | Not publicly available | Same |
| Battery | li-ion battery pack;rechargeable, 24 VDC 20Ah | Li-ion, Rechargeable; 24 VDC20Ah | Same |
| Maximum distanceof travel on the fullycharged battery | 20 km | 20 km | Same |
| Main frame material | aluminum alloy | Not publicly available | Same |
| seat cushion | Nylon braided belt | Not publicly available | n/a |
| Armrest cushion | PU (polyurethane) | Not publicly available | n/a |
| Differences | |||
| Overall dimensions(LxWxH) | 1110 mm x 700 mm x 980 mm | Not publicly available | n/a |
| Folded dimensions(LxWxH) | 810 mm x 700 mm x 400 mm | Not publicly available | n/a |
| Ground clearance | 160 mm | Not publicly available | n/a |
| Front wheelsize/type | 8" x 2"/PU Solid tire | Not publicly available | n/a |
| Rear wheel size/type | 10"x 3"/Pneumatic tire | Not publicly available | n/a |
| Max speed forward | 0-1.5m/s (5.4 km/h),continuously adjustable | Not publicly available | n/a |
| Max Speedbackward | 0.8m/s (2.88km/h) | Not publicly available | n/a |
| Minimum brakingdistance frommaximum speed | Forward: 1.0 m | Not publicly available | n/a |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| Minimum braking time from maximum speed | 0.7 second | Not publicly available | n/a |
| Max loading weight | 125 kg (275 lbs) | Not publicly available | n/a |
| Maximum safe operational incline degree | 8 ° | Not publicly available | n/a |
| Battery charger | Off-board chargerInput: 100-240V, 50/60Hz, 2.5A,Output: 24 Vdc, 6A; Charging time: 6 hours | Off-board, Automatic TypeInput: 110-220 V / 50-60 Hz,Output: 24 Vdc, 2A; | SimilarOutput current difference will impact charging time only, which will not cause new safety and effectiveness concerns raised. |
| Motor | brushless motor; 24VDC; 200W; 2pcs | Brushless DC motor; 24 VDC; 180 W; 2 pcs | Similarminor difference on motor power will not cause different performance. larger power will provide more driving force, no safety and effectiveness concerns raised. |
| Electronic controller | newVSi ELECTRIC WHEELCHAIR CONTROL SYSTEM, 50A manufactured by PG DRIVES TECHNOLOGY LTD. | Brushless dual-drive rocker controller | DifferentAlthough different controller is used, both the control system, including the joystick controller, the electromagnetic brakes and the user interface are similar. The joystick controls the directions and speed of movement, and when the joystick is released, the powered wheelchair will slow down to stop and the brakes will automatically re-engage. The controller also provides the battery status displaying and abnormal condition displaying. Both of the control systems are evaluated according to |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| Turning Radius | 950 mm | Not publicly available | n/a |
| Maximum obstacleclimbing | 50 mm | Not publicly available | n/a |
| thick seat cushion/back cushion | sandwich mesh fabric(polyester) | Not publicly available | n/a |
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VII. Summary of substantial equivalence discussion
The Y207 INTCO electric wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2001, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2001, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1:2005+A1:2012, IEC 60601-1-2: 2014, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010.
The intended uses for both devices are the same. Mainframes of two devices are folded by way of front and rear close, and frame materials all meet the Tensile Strength, Yield Load, and Elongation tests. The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14:2008. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012. Maximum obstacle climbing and Maximum safe operational incline are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2:2001, ISO 7176-10:2008. The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2010.
The flame retardant test of the seat cushion/back cushion and armrest of both subject device and predicate device is carried out according to the ISO 7176-16 test. Therefore, both devices are assured to be under the same safety level.
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In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device 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. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
VIII. Summary of non-clinical testing (Performance testing-bench)
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971:2007.
- Software evaluation
- . ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- . ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
- . ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- . ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
- ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- . ISO 7176-7:1998 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 strength
- . ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- . ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
- ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of
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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 7176-16:2012 Wheelchairs -- Part 16: Resistance to ignition of postural support devices
- ISO 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs
- Electrical Safety Testing in accordance with IEC 60601-1:2005 (3rd Edition)
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
- IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
IX. Biocompatibility of patient-contacting material
Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010). Details of the test summary see section 12 biocompatibility summary.
| Component name | Material | Direct contact/indirect contact | Contact body | Contact duration | Evaluation tests | Conclusion |
|---|---|---|---|---|---|---|
| Normal Seat cushion/Back cushion | Oxford fabric | Direct | intact skin surface | <24 Limited | Cytotoxicity,irritation,sensitization | TBD |
| Back cushion / Thick seat cushion | sandwich mesh fabric (polyester) | Direct | intact skin surface | <24 Limited | Cytotoxicity,irritation,sensitization | Pass |
| Handle foam tube | EVA foaming (ethylene-vinyl acetate copolymer) | Direct | intact skin surface | <24 Limited | Cytotoxicity,irritation,sensitization | TBD |
| Armrest cushion | PU leather (polyurethane) | Direct | intact skin surface | <24 Limited | Cytotoxicity,irritation, | TBD |
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| sensitization | ||||||
|---|---|---|---|---|---|---|
| newVSi electric wheelchair controller | ||||||
| Joystickknob | Santoprene101-80 | Direct | intact skinsurface | <24Limited | Cytotoxicity | Pass |
| JoystickGaiter | Silicone(50%) & 5031(50%) | Direct | intact skinsurface | <24Limited | Cytotoxicity | Pass |
| EnclosureMoulding(s) | ABS/PCWonderloyPC-540 | Direct | intact skinsurface | <24Limited | Cytotoxicity | Pass |
| Keypad | Silicone keypadcoatings TC-2407& CH-6330 | Direct | intact skinsurface | <24Limited | Cytotoxicity | Pass |
Summary of clinical testing X.
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electric wheelchair to its predicate device.
Conclusions XI.
The differences between Y207 electric wheelchair and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that Y207 INTCO electric wheelchair is substantially equivalent to the legally marketed predicate device.
N/A