Scooter

K182471 · Tianjin Kepler Vehicle Industry Co. , Ltd. · INI · Jul 10, 2019 · Physical Medicine

Device Facts

• Record ID: K182471
• Device Name: Scooter
• Applicant: Tianjin Kepler Vehicle Industry Co. , Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Jul 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

It 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.

Device Story

The KPL001 is an electric, three-wheeled motorized scooter for indoor/outdoor mobility. It features a carbon steel frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, and a tiller console. The device is powered by a 24V 180W motor and rechargeable lead-acid batteries. The rider controls movement via a throttle lever, speed control dial, and handle on the tiller console. An electromagnetic brake engages automatically when the device is not in use. The scooter is designed for disassembly without tools for transport. The device provides mobility assistance to disabled or elderly users, potentially improving their independence. It is intended for operation by the user.

Clinical Evidence

No clinical data. Bench testing only. The device demonstrated compliance with the ISO 7176 series (stability, braking, energy consumption, dimensions, speed, fatigue, climatic tests, obstacle climbing, EMC, and battery/charger safety) and ISO 10993 (biocompatibility).

Technological Characteristics

Carbon steel frame; 24V 180W electric motor; 24V/12AH lead-acid battery; electromagnetic braking system; rear-wheel drive. Dimensions: 1030mm x 630mm x 920mm. Compliance with ISO 7176 series (stability, performance, EMC) and ISO 10993 (biocompatibility).

Indications for Use

Indicated for disabled or elderly persons with mobility limitations who are able to walk but require a seated transportation vehicle for indoor and outdoor use.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Predicate Devices

• Solax Electric Scooter (K172440)
• C.T.M. Mobility Scooter (K162952)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 10, 2019

Tianjin Kepler Vehicle Industry Co. Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 Cn

Re: K182471

Trade/Device Name: Scooter KPL001 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 9, 2019 Received: April 11, 2019

Dear Ray 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/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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek Pinto, PhD Assistant Director 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) K182471

Device Name Scooter, Model: KPL001

Indications for Use (Describe)

It 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.

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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This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K182471

- Date of Preparation 1.
07/10/2019

- 2. Sponsor
### TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD.

Xinmin Road, West Area of Economic and Technological Development Zone, TianJin 300462, China Contact Person: ChunXi Zhang Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent
Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Tel: [phone] Fax: [phone] Email: ray.wang(@believe-med.com

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#### 4. Identification of Proposed Device

Trade Name: Scooter Common Name: vehicle, motorized 3-wheeled Model(s): KPL001

Regulatory Information: Classification Name: vehicle, motorized 3-wheeled Classification: 2; Product Code: INI; Regulation Number: 21 CFR 890.3800; Review Panel: Physical Medicine;

Intended Use Statement:

It 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.

- 5. Device Description
The Scooter (Models: KPL001) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has a base with metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, rechargeable lead-acid battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually.

The parts of Scooter, such as seat, rear, basket, batteries cover, could be disassembled easily. No tools will need in installation or uninstallation.

The Scooter could be detached as following steps:

- Before operating, the knob is in the horizontal direction, then Push the lock konb forward and a. point to the key hole ,turn it 90 degree clockwise, the tiller will be locked in a straight ahead position.
- Separating the seat from the scooter by lifting up the seat. If the seat is blocked while you are b. removing it, please loosen the seat while lifting it and turn the seat back.
- Separating the batteries from the scooter by lifting up the battery pack. C.

And, the scooter could be installed as following steps:

- Firstly, use the quick release handle to lift the frame. a.
- b. Then, put the motor support forward, the frame hook is correctly attached to the tube.
- Turn the tiller to a high position and tighten the tiller button. C.
- d. The re installation of the batteries.
- Reinstalling the seat, and turning it until it is fixed in right place. e.
- f. The counterclockwise rotation of a knob, unlock the tiller.

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#### 6. Identification of Predicate Device

Predicate #1 510(k) Number: K172440 Product Name: Solax Electric Scooter Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.

Predicate #2 510(k) Number: K162952 Product Name: C.T.M. Mobility Scooter Manufacturer: Chien Ti Enterprise Co., Ltd.

#### Non-Clinical Test Conclusion 7.

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 7176-2:2001 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 manoeuvring 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 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 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 method.

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 - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers

ISO 7176-22:2014 Wheelchairs – Part 22: Set-up procedures

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ISO 7176-25:2013 Wheelchairs – Part 25: Batteries and chargers for powered wheelchairs ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10: 2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

- 8. Clinical Test Conclusion
No Clinical Test conducted.

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# 9. Substantially Equivalent (SE) Comparison

| Table 1 General Comparison | | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------|
| ITEM | Proposed Device<br>K182471 | Predicate Device #1<br>K172440 | Predicate Device #2<br>K162952 | Remark |
| Product Code | INI | INI | INI | SE |
| Regulation No. | 21 CFR 890.3800 | 21 CFR 890.3800 | 21 CFR 890.3800 | SE |
| Class | 2 | 2 | 2 | SE |
| Indication For<br>Use | It 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. | It 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. | The C.T.M. Mobility Scooter HS-328 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person. | SE |
| Operation<br>Environment | For Indoor/Outdoor use | For Indoor/Outdoor use | For Indoor/Outdoor use | SE |

## Table 1 General Comparison

# Table 2 Performance Comparison

| ITEM | Proposed Device | Predicate Device #1 | Predicate Device #2 | Remark |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------|----------|
| | K182471 | K172440 | K162952 | |
| Overall<br>Dimensions | 1030mm/40.6" x 630mm/24.8" x 920mm/36.2" | 930mm/36.6" x 450mm/17.7" x 865mm/34.1" | 1120mm/44" x 590mm/23.2" x 935mm/36.8" | Analysis |
| Tires | 7" (190 x 54 mm) for front wheel (solid wheel)<br>8" (215 x 70 mm) for rear wheel (solid wheel) | 6 inches (160 x 45 mm) for front wheel (solid wheel)<br>7 inches (190 x 70 mm) for rear wheel (solid wheel) | Front wheels: 225mm/9"<br>Rear wheels: 225mm/9" | Analysis |
| Speed | 6.6 km/h | 6 kmh/3.7 mph | 8 kmh/ 5 mph | Analysis |
| Safe<br>Gradient/Maximum Gradient | | | 8° | SE |
| Range | 15 km/9.32 Miles | 15 km / 9.32 Miles | 17.5 kg / 10.9 Miles | SE |
| Turning Circle | 1.3 m/51.2" | 1.55 m/61" | 1.45m/57.1" | Analysis |
| Base weight (not<br>including battery) | 50 kg/110 lbs | 24 kg/ 53 lbs | 55kg/121.3 lbs | Analysis |
| Battery Weight | 10.2 kg/22.5 lbs | 1.84 kg/4.1 lbs | 15.5 kg/34.2 lbs | Analysis |
| Brake | Electromagnetic | Electromagnetic | Electromagnetic | SE |
| Drive System | Rear wheel drive | Rear wheel drive | Rear wheel drive | SE |
| Distance-Normal<br>operation<br>(Horizontal-Forward-Max speed) | 1m/39.4" | No available data | 1.3m/51.2" | Analysis |
| Time to brake | < 1 s | No available data | No available data | Analysis |
| Operating surface<br>&environment | Indoor use and restricted outdoor use on pavements<br>or paved footpaths only. | Indoor and outdoor use | Indoor and outdoor use | SE |
| Frame material | Carbon steel | No available data | No available data | Analysis |
| Frame style | Foldable seat, removable battery pack, disassemble<br>for transport | adjustable steering column, removable battery pack,<br>fold for transport | Disassemble for transport | SE |
| Frame tube size | ⌀25.4 | No available data | No available data | Analysis |
| Obstacle Climbing<br>Ability | 50 mm/1.97" | 38 mm/1.5" | 52 mm/2" | Analysis |
| Maximum<br>Capacity | 120 kg/265 lbs approx | 125 kg/276 lbs Approx. | 136 kg/300 lbs | Analysis |
| Ground Clearance | 45 mm/1.8" | 36 mm/1.4" | 40mm/1.6" | Analysis |
| Battery | lead-acid 24V/12AH | Lithium battery 24 V/10AH | Lead-Acid 12V/22Ah x 2 | Analysis |
| Motor | 24 V 180W | 24V 120W | No available data | Analysis |
| Battery Charger | DC 24V/2A | DC 24V/2A | DC 24V/5A | SE |
| ITEM | Proposed Device | Predicate Device #1 | Predicate Device #2 | Remark |
| | K182471 | K172440 | K162952 | |
| Performance Test | Comply with ISO 7176 series | Comply with ISO 7176 series | Comply with ISO 7176 series | SE |
| EMC | Comply with IEC 60601-1-2 and ISO 7176-21 | Comply with ISO 7176-21 | Comply with ISO 7176-21 | SE |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Label and<br>Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | SE |

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# Difference Analysis:

The design and technological characteristics of the is basically similar to the predicate device chosen. There are ninor differences between the devices including overall dimensions, tire size, basic weight, battery weight, brake distance, ime to brake, obstacle climbing ability, Maximum capacty, Ground clearance, Battery and motor. There is no cffectiveness due to the differences, and these minor differences do not influence the intended use finetion and use of the device, the non-clinical tests and the predicate comparisons chat these differences in their technological characteristics do not raise any questions as to the safety and effectiveness.

Therefore, the subject device is substantially equivalent to the Solax Electric Scooter (K172440) and C.T.M. Mobility Scooter (K162952).

# Table 3Safety Comparison

# Table 4 Test results of ISO 7176 series comparison

| ITEM | Proposed Device | Predicate Device #1 | Predicate Device #2 | Remark | |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----|
| | K182471 | K172440 | K162952 | | |
| ISO 7176-1 | The Static stability has been determined after the<br>testing according to the ISO 7176-1, and test results<br>meet it's design specification. | The Static stability has been determined after the<br>testing according to the ISO 7176-1, and test results<br>meet it's design specification. | The Static stability has been determined after the<br>testing according to the ISO 7176-1, and test results<br>meet it's design specification. | SE | |
| | ISO 7176-2 | The dynamic stability has been determined after the | The dynamic stability has been determined after the | The dynamic stability has been determined after the | SE |
| | testing according to the ISO 7176-2, and test results<br>meet it's design specification. | testing according to the ISO 7176-2, and test results<br>meet it's design specification. | testing according to the ISO 7176-2, and test results<br>meet it's design specification. | | |
| ISO 7176-3 | The effectiveness of brakes has been determined after<br>the testing according to the ISO 7176-3, and test<br>results meet it's design specification. | The effectiveness of brakes has been determined after<br>the testing according to the ISO 7176-3, and test<br>results meet it's design specification. | The effectiveness of brakes has been determined after<br>the testing according to the ISO 7176-3, and test<br>results meet it's design specification. | SE | |
| ISO 7176-4 | The theoretical distance range has been determined<br>after the testing according to the ISO 7176-4, and test<br>results meet it's design specification. | The theoretical distance range has been determined<br>after the testing according to the ISO 7176-4, and test<br>results meet it's design specification. | The theoretical distance range has been determined<br>after the testing according to the ISO 7176-4, and test<br>results meet it's design specification. | SE | |
| ISO 7176-5 | The dimensions, mass has been determined after the<br>testing according to the ISO 7176-5, | The dimensions, mass has been determined after the<br>testing according to the ISO 7176-5, | The dimensions, mass has been determined after the<br>testing according to the ISO 7176-5, | SE | |
| ISO 7176-6 | The maximum speed, acceleration and deceleration of<br>scooter has been determined after the testing<br>according to the ISO 7176-6, | The maximum speed, acceleration and deceleration of<br>scooter has been determined after the testing<br>according to the ISO 7176-6, | The maximum speed, acceleration and deceleration of<br>scooter has been determined after the testing<br>according to the ISO 7176-6, | SE | |
| ISO 7176-7 | The seating and wheel dimensions has been<br>determined after the testing according to the ISO<br>7176-7, | The seating and wheel dimensions has been<br>determined after the testing according to the ISO<br>7176-7, | The seating and wheel dimensions has been<br>determined after the testing according to the ISO<br>7176-7, | SE | |
| ISO 7176-8 | All test results meet the requirements in Clause 4 of<br>ISO 7176-8 | All test results meet the requirements in Clause 4 of<br>ISO 7176-8 | All test results meet the requirements in Clause 4 of<br>ISO 7176-8 | SE | |
| ISO 7176-9 | The test results shown that the device under tests<br>could continue to function according to<br>manufacturer's specification after being subjected to<br>each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests<br>could continue to function according to<br>manufacturer's specification after being subjected to<br>each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests<br>could continue to function according to<br>manufacturer's specification after being subjected to<br>each of the tests specified in Clause 8 of ISO 7176-9 | SE | |
| ISO 7176-10 | The obstacle-climbing ability of device has been<br>determined after the testing according to the ISO<br>7176-10, | The obstacle-climbing ability of device has been<br>determined after the testing according to the ISO<br>7176-10, | The obstacle-climbing ability of device has been<br>determined after the testing according to the ISO<br>7176-10, | SE | |
| ISO 7176-11 | The test dummies used in the testing of ISO 7176 | The test dummies used in the testing of ISO 7176 | The test dummies used in the testing of ISO 7176 | SE | |
| | series are meet the requirements of ISO 7176-11 | series are meet the requirements of ISO 7176-11 | series are meet the requirements of ISO 7176-11 | | |
| ISO 7176-13 | The coefficient of friction of test surfaces has been | The coefficient of friction of test surfaces has been | The coefficient of friction of test surfaces has been | SE | |
| | determined, which could be used in other 7176 series | determined, which could be used in other 7176 series | determined, which could be used in other 7176 series | | |
| | tests involved | tests involved | tests involved | | |
| ISO 7176-14 | All test results meet the requirements in Clause 7, 8, | All test results meet the requirements in Clause 7, 8, | All test results meet the requirements in Clause 7, 8, | SE | |
| | 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | | |
| ISO 7176-15 | The test results shown that information disclosure, | The test results shown that information disclosure, | The test results shown that information disclosure, | SE | |
| | documentation and labelling of device meet the | documentation and labelling of device meet the | documentation and labelling of device meet the | | |
| | requirements of ISO 7176-15 | requirements of ISO 7176-15 | requirements of ISO 7176-15 | | |
| ISO 7176-16 | The performance of resistance to ignition meet the | The performance of resistance to ignition meet the | The performance of resistance to ignition meet the | SE | |
| | requirements of ISO 7176-16 | requirements of ISO 7176-16 | requirements of ISO 7176-16 | | |
| ISO 7176-21 | The EMC performance results meet the requirements | The EMC performance results meet the requirements | The EMC performance results meet the requirements | SE | |
| | of ISO 7176-21 | of ISO 7176-21 | of ISO 7176-21 | | |
| ISO 7176-22 | All performed tests are set up as requirements of ISO | All performed tests are set up as requirements of ISO | All performed tests are set up as requirements of ISO | SE | |
| | 7176-22 | 7176-22 | 7176-22 | | |
| ISO 7176-25 | The performance of batteries and charger of device | The performance of batteries and charger of device | The performance of batteries and charger of device | SE | |
| | meet the Requirements in Clause 5 and 6 of ISO | meet the Requirements in Clause 5 and 6 of ISO | meet the Requirements in Clause 5 and 6 of ISO | | |
| | 7176-25 | 7176-25 | 7176-25 | | |

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# 10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.