(58 days)
Not Found
No
The device description and summary of performance studies focus on standard mobility scooter components and compliance with relevant ISO standards, with no mention of AI, ML, image processing, or data training/testing sets typically associated with AI/ML technologies.
No
This device is a mobility aid for transportation, not a therapeutic device designed for treatment or rehabilitation.
No
This device is a mobility scooter designed for transportation, not for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including a steel frame, wheels, seat, tiller console, electromagnetic brake, and batteries. The testing also references standards related to physical characteristics and performance of a mobility device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a "motor driven, indoor and outdoor transportation vehicle" intended to "provide mobility to a disabled or elderly person limited to a seated position." This is a physical mobility aid, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, preparing, or analyzing biological specimens. There is no mention of reagents, assays, or any other elements typically associated with IVD devices.
- Relevant Standards: The listed standards (ISO 7176 series) are related to wheelchairs and mobility scooters, not IVD devices.
Therefore, based on the provided information, this mobility scooter is a medical device, but it falls under a different category than In Vitro Diagnostics.
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 Mobility Scooter, Models: W3431D, has a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries 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 (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 10993-5: 2009, ISO 10993-10: 2010, ISO 7176-1: 2014, ISO 7176-2:2017, ISO 7176-3: 2012, ISO 7176-4, ISO 7176-5, ISO 7176-6: 2018, ISO 7176-7, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO 7176-13, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-21:2009, ISO 7176-25:2013.
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
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July 14, 2023
Zhejiang Innuovo Rehabilitation Devices Co., Ltd % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Century Ave., Shanghai, Shanghai 200122 China
Re: K231428
Trade/Device Name: Mobility Scooter (Models: W3431D) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: May 17, 2023 Received: May 17, 2023
Dear Jarvis Wu:
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.
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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. Julia E. Slocomb 2023.07.14 09:18:05 -04'00' -5 for 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
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Indications for Use
510(k) Number (if known) K231428
Device Name Mobility Scooter (Models: W3431D)
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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510(K) Summary
Document Prepared Date: 2023/4/27
Applicant: A.
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China Contact Person: Grace Li Tel: + 86 15924234767
Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: zxfda@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Mobility Scooter (Models:W3431D) Common Name: Scooter Model: W3431D 510Knumber: K231428 Regulatory Information Classification Name: Motorized three-wheeled vehicle Classification: Class II. Product code: INI Regulation Number: 890.3800 Review Panel: Physical Medicine
C. Predicate device:
510Knumber: K222507
Device Name: Mobility Scooter
Model: W3431Q, W3431R
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
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D. Indications for use of the device:
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.
E. Device Description:
The Mobility Scooter, Models: W3431D, has a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries 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 TestConclusion
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 PoweredWheelchairs >
- 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 ofelectric 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 abilityof 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 friction of test surfaces
-
ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electricallypowered 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 supportdevices.
- ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods forelectromagnetic V
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- ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered wheelchairs >
G. Clinical TestConclusion
No clinical study is included in this submission.
H. Comparison with predicate Device
Table 1 General Comparison
| Elements of
| Comparison | Subject Device (K231428) | Predicate Device (K222507) | Remark |
|---|---|---|---|
| Manufacturer | Zhejiang Innuovo Rehabilitation | ||
| Devices Co.,Ltd | Zhejiang Innuovo Rehabilitation | ||
| Devices Co.,Ltd | Same | ||
| Common or | |||
| Usual name | Scooter | Scooter | Same |
| Model(s) | W3431D | W3431Q, W3431R | -- |
| 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. | 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. | ||
| Overall | |||
| dimension | 1020 mm x 500 mm x 840 mm | 1020 mm x 500 mm x 840 mm | S.E. |
| Frame | |||
| Material | Steel | Steel | S.E. |
| Frame style | Foldable seat, removable battery pack, | ||
| disassemble for transport | Foldable seat, removable battery pack, | ||
| disassemble for transport | S.E. | ||
| Front wheel | |||
| size | 190 x 55 mm | 190 x 55 mm | S.E. |
| Front Wheels | |||
| Quantity | 2 | 2 | S.E. |
| Rear wheel | |||
| size | 190 x 55 mm | 190 x 55 mm | S.E. |
| Rear Wheels | |||
| Quantity | 2 | 2 | S.E. |
| Ground | |||
| clearance | 45 mm | 45 mm | S.E. |
| Max | |||
| Loading( on | |||
| level ground) | 120kg | 120kg | S.E. |
| Turn Radius | 1650mm | 1650mm | S.E. |
| Motor output | 24 V 180W | 24 V 180W | S.E. |
| Drive System | Rear Wheel Drive | Rear Wheel Drive | S.E. |
| Brakes | Electromagnetic brake | Electromagnetic brake | S.E. |
| Battery | Lead-acid 12V12Ah*2 | Lead-acid 12V12Ah*2 | S.E. |
| Charger | 24V/2A | 24V/2A | S.E. |
| Max Speed | 6 km/h | 6 km/h | S.E. |
| Slope Grade | |||
| Ability | 9 degree | 9 degree | S.E. |
| Travel | |||
| Distance | 15 km/9.32 Miles | 15 km/9.32 Miles | S.E. |
| Arm Rests | |||
| (Distance | |||
| between | |||
| armrests) | 44-56 cm | 44-56 cm | S.E. |
| Controller | PG45A | 45A | Analysis |
| Time to | |||
| brake | 0.7-1s |