(60 days)
Not Found
No
The description focuses on mechanical and electrical components and user-controlled operation. There is no mention of AI, ML, or any adaptive or learning capabilities.
No
The device is described as a transportation vehicle to provide mobility, not to treat, cure, or prevent a disease or condition, or to affect the structure or function of the body as a therapeutic device would.
No
The device is described as a transportation vehicle to provide mobility, not to diagnose any condition.
No
The device description clearly outlines numerous hardware components including a frame, wheels, seat, motor, brake, battery, and remote control switch. It is a physical mobility device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Mobility Scooter Function: The description clearly states the mobility scooter's intended use is for "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 physical aid for movement, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, analysis, reagents, or diagnostic testing.
The information provided describes a mobility device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The mobility scooter 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
This mobility scooter 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 Mobility Scooter, Model N3473, has a base with magnesium alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger, a remote control switch. 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
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:
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- . ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- . ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
- ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs ● and scooters for determination of theoretical distance range
- . ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
- . ISO 7176-6:2018 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 strength
- ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- . ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
- ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
- . ISO 7176-14:2022 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 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices – Requirements and test method
- ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for . electromagnetic compatibility of electrically powered wheelchairs and scooters
- . ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
- . ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020.
No clinical study is included in this submission.
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 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 9, 2024
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, Dongfang Building, 1500# Century Ave Shanghai. 200122 China
Re: K242387
Trade/Device Name: Mobility Scooter (N3473) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 12, 2024 Received: August 12, 2024
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 (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.
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"
1
(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-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 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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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).
2
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Mobility Scooter
Indications for Use (Describe)
The mobility scooter 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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4
510(k) Summary
K242387
l. Applicant
Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang, China
Name of contact person: Grace Li
Tel: +86 15924234767
Fax: +86-579-89327232
Email: Lss@kf-innuovo.com
Date prepared: 2024-10-04
II. Submission Correspondent
Ms. Ivy Wang
Shanghai Sungo Management Consulting Co., Ltd.
Tel: +86-21-5881 7802
Email: haiyu.wang@sungoglobal.com
III. Device
Device trade name: Mobility Scooter
Model: N3473
Regulatory Information:
Classification name: Vehicle, motorized 3-wheeled
Regulation class: 2
Regulation number: 21CFR 890.3800
Panel: Physical Medicine
Product code: INI
IV. Predicate device
K201196 Device Name: Scooter Model: FDB01
5
Nanjing Jin Bai He Medical Apparatus Co. Ltd.
V. Device description
This mobility scooter 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 Mobility Scooter, Model N3473, has a base with magnesium alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger, a remote control switch. 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.
VI. Indication for use
The mobility scooter 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.
VII. Comparison with the predicate device
| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| Manufacturer | Zhejiang | ||
| Rehabilitation | |||
| Co., Ltd. | Innuovo Nanjing Jin Bai He Medical | ||
| Devices Apparatus Co. Ltd. | / | ||
| Proprietary name, | |||
| model | Mobility Scooter | ||
| N3473 | Scooter, FDB01 | / | |
| 510(k) number | K242387 | K201196 | / |
| Device classification | |||
| name | Class II | Class II | Same |
| Classification | |||
| regulations | 21 CFR 890.3800 | 21 CFR 890.3800 | Same |
| Product code | INI | INI | Same |
| Similarities | |||
| Indication for use | The mobility scooter is a | ||
| motor driven, indoor and | |||
| outdoor transportation | |||
| vehicle with the intended | It is a motor driven, indoor | ||
| and outdoor transportation | |||
| vehicle with the intended | |||
| use to provide mobility to a | Same |
| Table 1 General Comparison | |||
|---|---|---|---|
| Attribute | Subject device | Predicate device | Results |
| use to provide mobility to a | |||
| disabled or elderly person | |||
| limited to a seated position. | use to provide mobility to a | ||
| disabled or elderly person | |||
| limited to a seated position. | use to provide mobility to a | ||
| disabled or elderly person | |||
| limited to a seated position. | 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 pivoting | ||
| casters and two rear drive | |||
| wheels | Same | ||
| Driving system | Direct drive on the rear | ||
| wheels | Direct drive on the rear | ||
| wheels | Same | ||
| Brake | Electromagnetic | Electromagnetic | Same |
| Time to brake |