(417 days)
Not Found
No
The description details a standard electric scooter with manual controls and an electromagnetic brake, with no mention of AI/ML capabilities or related performance studies.
No
The device is a transportation vehicle designed to provide mobility for disabled or elderly individuals; it does not directly treat or cure any medical condition.
No
Explanation: The device is described as an indoor/outdoor electric scooter intended to provide mobility. It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly outlines numerous hardware components including a frame, wheels, seat, motor, brake, and batteries. It is a physical mobility device, not a software-only application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to disabled or elderly persons. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical transportation vehicle with mechanical and electrical components. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic results.
- Performance Studies: The performance studies focus on compliance with standards related to wheelchairs and mobility devices (ISO 7176 series), as well as biocompatibility (ISO 10993 series). These are not typical standards for IVD devices.
In summary, the device is a mobility aid, not a diagnostic tool.
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: FDB01) 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, 2 rechargeable Lithium-Ion 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 Scooter only can be operated on the flat road.
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
disabled or elderly person
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
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 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
- ISO 7176-1: 2014, Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs
- ISO 7176-3: 2012, Wheelchairs - Part 3: Determination of effectiveness of brakes
- ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- ISO 7176-5. Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
- ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
- ISO 7176-7, Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- ISO 7176-8:2014, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered Wheelchairs
- ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.
- ISO 7176-13. First edition 1989-08-01. Wheelchairs - Part 13: Determination of coefficient 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 7176-16:2012 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 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
No clinical study is included in this submission.
Key Metrics
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
June 25, 2021
Nanjing Jin Bai He Medical Apparatus Co., Ltd % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500#Central Ave. Shanghai, Shanghai 200122 China
Re: K201196
Trade/Device Name: Scooter (Model: FDB01) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 2, 2021 Received: April 2, 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/cfpm/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.
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
2
Indications for Use
510(k) Number (if known) K201196
Device Name Scooter (Model: FDB01)
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)
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."
3
510(K) Summary
Date of Preparation: 6/9/2021
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92
A. Sponsor Information
Nanjing Jin Bai He Medical Apparatus Co., Ltd Address: No. 12, Wuge Rd, Jiangning, Nanjing City, Jiangsu, 211113, China Contact Person: Dandan Yang Tel: +86-25-85780899
Submission Correspondent
Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com
B. Subject device
| Trade Name: | Scooter (Model: FDB01) |
|---|---|
| Common Name: | Scooter |
| Classification Name: | Motorized three-wheeled vehicle |
| Product code: | INI |
| Classification: | II |
| Regulation Number: | 890.3800 |
| Review Panel: | Physical Medicine |
C. Predicate device
1st Predicate device (Primary):
| Sponsor | TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD. |
|---|---|
| Device Name | Scooter (KPL001) |
| 510Knumber | K182471 |
2nd Predicate device
| Sponsor | Dongguan Prestige Sporting Goods Co., Ltd |
|---|---|
| Device Name | Solax Electric Scooter |
| 510Knumber | K172440 |
D. 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.
4
E. Device Description
The Scooter (Models: FDB01) 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, 2 rechargeable Lithium-Ion 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 Scooter only can be operated on the flat road.
F. Non-Clinical Test Conclusion
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:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-
ISO 7176-1: 2014, Wheelchairs - Part 1: Determination of static stability
- V ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs
-
ISO 7176-3: 2012, Wheelchairs - Part 3: Determination of effectiveness of brakes
-
ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
-
ISO 7176-5. Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
-
ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
-
ISO 7176-7, 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
- A ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered Wheelchairs
-
ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
-
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.
-
ISO 7176-13. First edition 1989-08-01. Wheelchairs - Part 13: Determination of coefficient 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 7176-16:2012 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
- A ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
G. Clinical Test Conclusion
No clinical study is included in this submission.
H. Comparison with predicate Device
5
Table 1 General Comparison
| Characteristic | Subject Device(s) | Primary Predicate Device
(K182471) | Secondary Predicate Device
(K172440) | Justification for
Substantial
Equivalence |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Manufacturer | Nanjing Jin Bai He Medical Apparatus Co., Ltd | Tianjin Kepler Vehicle Industry Co. Ltd. | Dongguan Prestige Sporting Goods Co., Ltd. | NA |
| Device Name | Scooter | Scooter | Solax Electric Scooter | NA |
| Model(s) | FDB01 | KPL001 | S302421 | NA |
| Indication 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. | 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. | S.E. |
| Frame Material | Aluminum alloy | Aluminum alloy | Metal alloy | S.E. to K182471 |
| Frame Design / Style | Electric scooter is driven by electricity scooter, is a
transportation tool and auxiliary tools for the
purpose of walking, without removing the battery
can be folded, easy to carry and storage. | Electric scooter is driven by electricity scooter, is a
transportation tool and auxiliary tools for the
purpose of walking, without removing the
battery can be folded, easy to carry and storage. | Electric scooter is driven by electricity scooter, is a transportation tool and auxiliary tools for the
purpose of walking, without removing the
battery can be folded, easy to carry and storage. | S.E. |
| Folding Mechanism | Seat can be folded; battery can be dismantled; The
frame can be folded back and forth. | Seat cannot be folded; battery can be
dismantled.It be dismantled foldable handlebar. | Seat can be folded; battery can be dismantled;
The frame can be folded back and forth. | S.E. |
| Seating Design | One-click folding intelligent electric scooter, with a
sensitive remote control, gently press, the car
automatically completed folding contraction,
folding volume small, electromagnetic automatic
brake, the overall simple design, convenient and
practical. Travel does not have to consume physical
force to do folding, poor physical strength and the
elderly the best walking tool.
Image: [scooter folded] | Only foldable handlebar
Image: [scooter folded] | One-click folding intelligent electric scooter,
with a sensitive remote control, gently press, the
car automatically completed folding contraction,
folding volume small, electromagnetic
automatic brake, the overall simple design,
convenient and practical, Travel does not have
to consume physical force to do folding, poor
physical strength and the elderly the best
walking tool.
Image: [scooter folded] | S.E. to K172440 |
| Seating Attachment -
integrated, power
base, specialty power | Without any seat accessories (integrated, power
base, dedicated power supply) | Without any seat accessories (integrated, power
base, dedicated power supply) | Without any seat accessories (integrated, power
base, dedicated power supply) | S.E. |
| Overall Dimensions | 1050mm X 550mm X 870mm | 1030mm X 630mm X 920mm | 930mm X 450mm X 865mm | Similar |
| Length | 1050 | 1030mm | 930mm | Similar |
| Width | 550 | 630mm | 450mm | Similar |
| Height | 870 | 920mm | 865mm | Similar |
| Seat Dimensions | | | | |
| Width | 438 | 420 | 430 | Similar |
| Depth | 385 | 350 | No data available | Similar |
| Height | 382 | 590 | 560 | Similar |
| Weight | 4kg | 11kg | No data available | Lighter then predicate |
| Folded Dimensions | | | | |
| Length | 480mm | No data available | 450mm | Similar |
| Width | 550mm | 1030mm | 450mm | Similar |
| Height | 790mm | 550mm | 640mm | Similar |
| Wheelchair Weight | | | | |
| With batteries | 29 | 50 | 24 | Similar to K172440 |
| Without batteries | 24.2 | 29.8 | 20.32 | Similar |
| Controller | British PG Controller PG45A | British PG Controller PG45A | British PG Controller PG45A | S.E. |
| Drive Style (e.g., rear,
mid, front) | Rear-wheel drive | Rear wheel drive | Rear wheel drive | S.E. |
| Motor Type | 24V DC brush differential rear axle | 24V DC brush differential rear axle | 24V DC brush differential rear axle | S.E. |
6
7
| Motor Output | 24V 180W | 24V 180W | 24V 120W | S.E. to K182471 |
|---|---|---|---|---|
| Batteries | Lithium battery | Lead Acid | Lithium battery | S.E. to K172440 |
| Quantity | 2 | 2 | No available data | S.E. to K182471 |
| Type | 24V 6AH | 24V/12AH | 24V/10AH | Similar |
| Chemistry | Lithium battery | Lead Acid | Lithium battery | S.E. to K172440 |
| Range per Charge | 6 hours | between 6 and 8 hours | 8-14 hours | S.E. to K182471 |
| Charger Type (On- | ||||
| board/Off- board/Carry- | ||||
| on) | Carry-on | Carry-on | Carry-on | S.E. |
| Input/Output Power | 100-240VAC 50/60Hz 1.2.-0.5A | 100-240V~50/60Hz 1.2A 120VA | ||
| Output: 29V 2A | 24V 2A/OUTPUT: 29.4V 2A | S.E. to K182471 | ||
| Actuator | Intelligent, Regenerative and | |||
| Electromagnetic brake system | Intelligent, Regenerative and | |||
| Electromagnetic brake system | Intelligent, Regenerative and | |||
| Electromagnetic brake system | S.E. | |||
| Brake | electromagnetic brake | electromagnetic brake | electromagnetic brake | S.E. |
| Minimum braking | ||||
| distance and time | 1.1 m for the speed of 6km/h | |||
| 1s | 1m for the speed of 6.6km/h |