(293 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on standard mechanical and electrical components.
Yes
The device is described as a transportation vehicle intended to provide mobility to a disabled or elderly person, which falls under the definition of a therapeutic device as it aids in treating a condition (mobility limitation).
No
The device is described as an indoor/outdoor electric scooter intended to provide mobility, not to diagnose a condition.
No
The device description explicitly lists numerous hardware components including a frame, wheels, seat, motor, brake, and battery, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a "motor driven, indoor and outdoor transportation vehicle" intended to "provide mobility to a disabled or elderly person limited to a seated position." It is a physical mobility aid.
- Lack of Biological Specimen Analysis: There is no mention of the device interacting with or analyzing any biological specimens.
- Focus on Mobility: The entire description and performance studies revolve around the physical function and safety of the scooter as a transportation device.
Therefore, based on the provided information, this device falls under the category of a mobility aid or personal transport device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
INI
Device Description
The Scooter (Models: R-100) 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 aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a rechargeable battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the control panel. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods.
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 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 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
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.
No Clinical Test conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 24, 2019
Yongkang Dingchang Industry & Trade 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: K182411
Trade/Device Name: Scooter, Model: R-100 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: May 23, 2019 Received: May 28, 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek Pinto, 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
2
Indications for Use
510(k) Number (if known) K182411
Device Name Scooter, Model: R-100
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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Tab #7 510(k) Summary
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: K182411
-
- Date of Preparation
06/20/2019
- Date of Preparation
-
Sponsor 2.
YONGKANG DINGCHANG INDUSTRY & TRADE CO., LTD.
No99, HuaxiRoad, Xicheng Street, YongKang City, Zhejiang Province, China Establishment Registration Number: Not yet registered or the Number Contact Person: Cheng Chen Position: General Manager Tel: +86- 579 87128717 Fax: +86- 579 87321558 Email: export(@ykdingchang.com
-
- Submission Correspondent
Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang(@believe-med.com
- Submission Correspondent
4
4. Identification of Proposed Device
Trade Name: Scooter Common Name: vehicle, motorized 3-wheeled Model(s): R-100
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.
ડ. Device Description
The Scooter (Models: R-100) 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 aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a rechargeable battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the control panel. 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.
5
6. Identification of Predicate Device
Predicate # 510(k) Number: K172440 Product Name: Solax Electric Scooter Manufacturer: Dongguan Prestige Sporting Goods 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:
EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods.
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 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 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
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
6
sensitization.
-
- Clinical Test Conclusion
No Clinical Test conducted.
- Clinical Test Conclusion
7
9. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Product Code | INI | INI | SE |
| Regulation No. | 21 CFR 890.3800 | 21 CFR 890.3800 | SE |
| Class | 2 | 2 | SE |
| 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. | 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. | SE | ||
| Operation | |||
| Environment | For Indoor/Outdoor use | For Indoor/Outdoor use | SE |
Table 1 General Comparison
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Overall | |||
| Dimensions | 1022 x 537 x | 930 x 450 x 865 mm | Analysis |
| Tires | 2 x 8 inches for front wheel (solid | ||
| wheel) | |||
| 3 x 9 inches for rear wheel (solid wheel) | 6 inches for front wheel (solid wheel) | ||
| 7 inches for rear wheel (solid wheel) | Analysis | ||
| Speed | 6.4 km/h (4 mph) | 6 km/h (3.7 mph) | SE |
| Safe | |||
| Gradient/Maximu | |||
| m Gradient | 0-6° | 0-12° | Analysis |
| Range | 20.25 km (12.6 miles) | 15 km (9.32 mile) | Analysis |
| Turning Circle | 1.16 m | 1.55 m | Analysis |
| Base weight (not | |||
| including battery) | 39.2 kg | 24 kg | Analysis |
| Battery Weight | 13.4 kg | 1.84 kg | Analysis |
| Brake | Electromagnetic | Electromagnetic | SE |
| Drive System | Rear wheel drive | Rear wheel drive | SE |
| Maximum | |||
| Capacity | 147 kg approx | 125 kg Approx. | Analysis |
| Ground Clearance | 76.2 mm | 36 mm | Analysis |
| Obstacle Climbing | |||
| Ability | 65 mm | 38 mm | Analysis |
| Battery | Battery, 24V/20AH | Lithium battery 24 V/10AH | Analysis |
| Motor | 24 V 200W | 24V 120W | Analysis |
| Battery Charger | DC 24V/2A | DC 24V/2A | SE |
Difference Analysis:
The design and technological characteristics of the subject device is basically similar to the predicate
8
device chosen. There are minor differences between the devices including overall dimensions, Tires, speed, Safe Gradient, range, Turning circle, basic weight, battery weight, Maximum capacity, Ground clearance, Battery and motor. There is no deleterious effect on safety and effectiveness due to the differences, and these minor differences do not influence the intended use function and use of the device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that 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).
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Performance Test | Comply with EN 12184 and 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 | SE | |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Label and | |||
| Labeling | Conforms to FDA Regulatory | ||
| Requirements | Conforms to FDA Regulatory | ||
| Requirements | SE |
Table 3 Safety Comparison
-
- 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.
- Substantially Equivalent (SE) Conclusion