Electric Wheelchair (Y207BL)
Device Facts
| Record ID | K253241 |
|---|---|
| Device Name | Electric Wheelchair (Y207BL) |
| Applicant | Jiangsu Intco Medical Products Co., Ltd. |
| Product Code | ITI · Physical Medicine |
| Decision Date | May 13, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3860 |
| Device Class | Class 2 |
Indications for Use
The Y207BL Electric Wheelchair is a motor driven, indoor and outdoor 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.
Device Story
Motor-driven electric wheelchair for indoor/outdoor mobility; intended for disabled or elderly users. Device comprises frame, seat/back upholstery, front/rear wheels, and electrical system (brushless motors, battery, controller, charger). User operates via joystick to control speed and direction; joystick release triggers automatic electromagnetic braking. Powered by 24V Li-ion battery. Device provides mobility assistance to users with limited physical capacity. Healthcare providers/caregivers do not operate the device; it is for patient use. Output is physical movement; controller provides battery status and abnormal condition displays. Benefits include improved independence for mobility-impaired individuals.
Clinical Evidence
No clinical data. Bench testing only, including ISO 7176 series (stability, braking, energy consumption, dimensions, strength, climatic, obstacle climbing, power/control systems, EMC) and ISO 16840-10 (ignition resistance).
Technological Characteristics
Aluminum alloy frame; brushless DC motors (24V, 200W x 2); 24V 12Ah Li-ion battery; brushless split-type controller. PU solid tires. Electromagnetic braking. Foldable design. Connectivity: off-board charger (100-240V AC). Biocompatibility per ISO 10993-1. Software validation per FDA guidance.
Indications for Use
Indicated for disabled or elderly individuals with mobility difficulties who are limited to a seated position, for indoor and outdoor transportation.
Regulatory Classification
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.
Predicate Devices
- Electric Wheelchair, Y207 (K202482)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 13, 2026
Jiangsu Intco Medical Products Co., Ltd.
% Boyle Wang
General Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong
Shanghai, 200120
China
Re: K253241
Trade/Device Name: Electric Wheelchair (Y207BL)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: April 15, 2026
Received: April 15, 2026
Dear Boyle 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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253241 - Boyle Wang
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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
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K253241 - Boyle Wang
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
Digitally signed by
ZACHARY MCKINNEY -S
Date: 2026.05.13
12:21:55 -04'00'
for Tushar Bansal, PhD
Acting 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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253241 | |
| Device Name Electric Wheelchair (Y207BL) | |
| Indications for Use (Describe) The Y207BL Electric Wheelchair is a motor driven, indoor and outdoor 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. | |
| Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ 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." | |
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510(k) Summary
# 510(k) Summary
# K253241
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
## 1.0 Submitter's information
Name: Jiangsu Intco Medical Products Co., Ltd.
Address: 298# Yandunshan Road, Zhenjiang, Jiangsu, 212132 China
Tel: +86-511-83174088
Contact: Terry Gu
## Designated Submission Correspondent
Mr. Boyle Wang
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China
Tel: +86-21-50313932
Email: Info@truthful.com.cn
Date of Preparation: Apr.14, 2026
## 2.0 Device information
Trade name: Electric Wheelchair
Common name: Electric Wheelchair
Classification name: Powered Wheelchair
Model(s): Y207BL
## 3.0 Classification
Production code: ITI
Regulation number: 21 CFR 890.3860
Classification: Class II
Panel: Physical Medicine
## 4.0 Predicate device information
510(k) Number: K202482
Product Name: Electric Wheelchair, Y207
Manufacturer: Jiangsu Intco Medical Products Co., Ltd.
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510(k) Summary
## 5.0 Indication for Use Statement
The Y207BL Electric Wheelchair is a motor driven, indoor and outdoor 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.
## 6.0 Device description
The Y207BL Electric Wheelchair is a motor driven, indoor and outdoor 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.
The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes brushless motor, battery box, brushless split-type controller and charger. The main parts of the wheelchair include front wheels, rear wheels, frame, foldable armrest, seat and back upholstery.
The device is powered by Li-ion Battery pack (24V 12Ah, 288Wh) with 15.1 Km (9.3 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.
## 7.0 Summary of Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
- ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
- ISO 7176-4:2008 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 overall dimensions, mass and manoeuvring space
- ISO 7176-6:2018 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 strengths
- 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
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510(k) Summary
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 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 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
ISO 7176-31:2023 Wheelchairs - Part 31: Lithium-ion battery systems and chargers for powered wheelchairs — Requirements and test methods
ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC TS 60601-4-2:2024 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
## Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Content of Premarket Submissions for Device Software Functions for software.
The Software Validation is in compliance with FDA Guidance.
## 8.0 Summary of Clinical Testing
No clinical study implemented for the electric wheelchair.
## 9.0 Technological Characteristic Comparison Table
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510(k) Summary
Table1-General Comparison
| Item | Proposed device | Predicate device | Remark |
| --- | --- | --- | --- |
| Manufacturer | Jiangsu Intco Medical Products Co.,Ltd. | Jiangsu Intco Medical Products Co.,Ltd. | Same |
| Product name | Electric Wheelchair, Y207BL | Electric Wheelchair, Y207 | / |
| 510(k) No. | K253241 | K202482 | / |
| Class | Class II | Class II | Same |
| Regulation No. | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | Same |
| Indication for use | The Y207BL Electric Wheelchair is a motor driven, indoor and outdoor 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. | The Y207 Electric Wheelchair is a motor driven, indoor and outdoor 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. | Same |
| Intended user | This product is suitable for disabled people with mobility difficulties and elderly people. | This product is suitable for disabled people with mobility difficulties and elderly people. | Same |
| Use condition | Indoor and outdoor use | Indoor and outdoor use | Same |
| Number of wheels | 4, including two front wheels and two rear wheels | 4, including two front wheels and two rear wheels | Same |
| Function of wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrograde Rear wheels: driving wheels to control the speed and direction | Front wheels: driven wheels suitable for rotation, acceleration, retrograde Rear wheels: driving wheels to control the speed and direction | Same |
| Movement control method | By Joystick control | By Joystick control | Same |
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510(k) Summary
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| --- | --- | --- | --- |
| Brake system | Automatic electromagnetic brake system | Automatic electromagnetic brake system | Same |
| Main frame material | Aluminum alloy | Aluminum alloy | Same |
| Motor | Brushless motor, DC24V* 200W*2pcs | Brushless motor; DC24V* 200W*2pcs | Same |
| Battery | li-ion battery pack; rechargeable, 24 VDC 12Ah | li-ion battery pack; rechargeable, 24 VDC 20Ah | Similar. Similar in type. The difference in capacity will affect the endurance time only, which will not cause new safety and effectiveness concerns raised. |
| Battery charger | Off-board charger Input: 100-240V~50/60Hz 1.5A Output: 29.4V 2000mA | Off-board charger Input: 100-240V, 50/60Hz, 2.5A, Output: 24 Vdc, 6A | Similar. Output current difference will impact charging time only, which will not cause new safety and effectiveness concerns raised. |
| Electronic controller | Brushless split - type controller | newVSi ELECTRIC WHEELCHAIR CONTROL SYSTEM, 50A, Manufactured by PG DRIVES TECHNOLOGY LTD. | Different. Although 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 |
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510(k) Summary
| | | | automatically re-engage. The controller also provides the battery status displaying and abnormal condition displaying. Both of the control systems are evaluated according to standard ISO 7176-14:2022 and software validation requirement and there are no new safety and effectiveness concerns due to the difference. |
| --- | --- | --- | --- |
Table2 Performance Comparison
| Item | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| Manufacturer | Jiangsu Intco Medical Products Co.,Ltd. | Jiangsu Intco Medical Products Co.,Ltd. | Same |
| Model | Y207BL | Y207 | / |
| Overall length | 1030mm | 1110 mm | Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Overall width | 640mm | 700 mm | |
| Folded length | 640mm | 810mm | |
| Folded width | 490mm | 700mm | |
| Folded height | 790mm | 400mm | |
| Total mass | 27kg | Not publicly available | - |
| Front wheel | 8 inch (PU solid tire) | 8 inch (PU solid tire) | Same |
| Rear tire | 12.5 inch (PU solid tire) | 10 inch (pneumatic tires) | Larger sizes of rear wheels bring steadier |
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510(k) Summary
| | | | pivoting function than predicate device. |
| --- | --- | --- | --- |
| Cruising Range | 15.1km | 20km | The subject device complies with ISO 7176-4: 2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range, these differences do not affect safety and effectiveness. |
| Obstacle climbing | 50mm | 50mm | Same |
| Static stability forward | 22.2° | Not publicly available | - |
| Static stability rearward | 21° | Not publicly available | |
| Static stability sideways | 21.1° | Not publicly available | |
| Max. loading | 136kg | 125kg | More loading weight means more convenient for the transportation |
| Min. Turning radium | 1200mm | 950mm | The devices are evaluated according to standard ISO 7176-5:2008, so the different will not impact the safety and effectiveness |
| Minimum braking distance | 0.97m | 1.0m | The devices are evaluated according to standard ISO |
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510(k) Summary
Table3 Safety Comparison
| Item | Proposed Device | Predicate Device K202482 | Remark |
| --- | --- | --- | --- |
| Materials contacting user | Armrest: PU; Footplates: PU Backrest/Seat: PVC Fabric Dashboard (Joystick/button): Silicone | Armrest: PU leather; Backrest/seat: sandwich mesh fabric (polyester) Normal Seat cushion/Back cushion: Oxford fabric Handle foam tube: EVA foaming (ethylene-vinyl acetate copolymer) newVSi electric wheelchair controller: Joystick knob: Santoprene 101-80; Joystick Gaiter: Silicone 3032 (50%) & 5031 (50%) Enclosure Moulding(s): ABS/PC Wonderloy PC-540 Keypad: Silicone keypad | Biocompatibility evaluation has been carried out per ISO 10993-1 and FDA guidance. There are no new safety and effectiveness concerns due to the difference. |
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510(k) Summary
| | | coatings TC-2407 & CH-6330 | |
| --- | --- | --- | --- |
| Biocompatibility Of materials contacting user | Comply with ISO 10993-1, FDA Guidance, tests included: In Vitro Cytotoxicity Test (ISO 10993-5:2009) Skin Sensitization Test (ISO 10993-10:2021) Intracutaneous Reactivity Test (ISO 10993-23:2021) | Comply with ISO 10993-1, FDA Guidance, tests included: Cytotoxicity (ISO 10993-5:2009), Sensitization and Intracutaneous Reactivity (ISO 10993-10:2010) | Same |
# Summary of substantial equivalence discussion:
The subject Electric Wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-14:2022, ISO 7176-15:1996, ISO 16840-10: 2021, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-31:2023, IEC 60601-1-2: 2020 and IEC TS 60601-4-2:2024
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 7176-14:2022. 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 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 7176-2:2017, ISO 7176-10:2008. The biocompatibility of the Predicate device and Subject device meet the requirements of the FDA guidance" Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Therefore, both devices are assured to be under the same safety level.
In conclusion, the technological characteristics, features, specifications, mode of operation, and intended use of the device substantially equivalent to that of 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.
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510(k) Summary
## 10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device under K202482.
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