(58 days)
Not Found
No
The description details a standard mobility scooter with manual controls and an electromagnetic brake. There is no mention of AI/ML terms, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration in medical devices.
No
The device is a mobility aid for transportation and does not treat or cure any medical condition.
No
The device is described as a mobility scooter intended for transportation, not for diagnosing medical conditions.
No
The device description clearly outlines numerous hardware components including a steel frame, wheels, seat, tiller console, electromagnetic brake, lights, USB port, and batteries. It is a physical mobility scooter, not a software-only device.
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 individuals. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a transportation vehicle with mechanical and electrical components. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on safety, durability, and compliance with standards related to mobility devices (ISO 7176 series), not diagnostic accuracy or analytical performance.
In Vitro Diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This mobility scooter does not fit that definition.
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 (comma separated list FDA assigned to the subject device)
INI
Device Description
The Mobility Scooter, Models W3468, has a base with Steal frame, two front wheels, a seat, a tiller console, electromagnetic brake, front light, USB charging port (Transfer power only), 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
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 and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with standards including ISO 10993-5, ISO 10993-10, and various parts of ISO 7176.
Specifically, performance evaluations against ISO 7176 series standards confirmed the following:
- ISO 7176-1: Static stability meets design specifications.
- ISO 7176-2: Dynamic stability meets design specifications.
- ISO 7176-3: Effectiveness of brakes meets design specifications.
- ISO 7176-4: Theoretical distance range meets design specifications.
- ISO 7176-5: Dimensions and mass meet design specifications.
- ISO 7176-6: Dimensions and mass meet design specifications. (Duplicate entry in original document)
- ISO 7176-7: Seating and wheel dimensions meet design specifications.
- ISO 7176-8: All test results meet the requirements in Clause 4 of ISO 7176-8.
- ISO 7176-9: The device continued to function according to manufacturer's specification after climatic tests specified in Clause 8 of ISO 7176-9.
- ISO 7176-10: Obstacle-climbing ability meets design specifications.
- ISO 7176-11: Test dummies used meet the requirements of ISO 7176-11.
- ISO 7176-13: Coefficient of friction of test surfaces was determined for use in other 7176 series tests.
- ISO 7176-14: All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14.
- ISO 7176-15: Information disclosure, documentation, and labeling meet the requirements of ISO 7176-15.
- ISO 7176-16: Performance of resistance to ignition meets the requirements of ISO 7176-16.
- ISO 7176-21: EMC performance results meet the requirements of ISO 7176-21.
- ISO 7176-25: Performance of batteries and charger meets the requirements in Clause 5 and 6 of ISO 7176-25.
Biocompatibility tests confirmed user-contacting materials comply with ISO10993-5 and ISO10993-10 requirements.
No clinical study was included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 and 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.
March 24, 2022
Zhejiang Innuovo Rehabilitation Devices Co., Ltd % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K220207
Trade/Device Name: Mobility Scooter (Model: W3468) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: January 25, 2022 Received: January 25, 2022
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.
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
1
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 L. Dean -S 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) K220207
Device Name Mobility Scooter (Model: W3468)
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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3
510(K) Summary
Document prepared date: 2022/1/21
Applicant: A.
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejjang.China Contact Person: Leo Zheng Tel: + 86 18358936043
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: haiyu.wang@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 Common Name: Scooter Model: W3468
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: K182471 Device Name: Scooter Model: KPL001 Tianjin Kepler Vehicle Industry Co. Ltd.
D. Indications for use of the device :
4
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 W3468, has a base with Steal frame, two front wheels, a seat, a tiller console, electromagnetic brake, front light, USB charging port (Transfer power only), 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 A Skin Sensitization
- ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability >
- A 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 A
-
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, A mass and manoeuvring space
- ISO 7176-6: 2018. Wheelchairs Part 6: Determination of maximum speed, acceleration and A 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 A
- ISO 7176-10:2008. Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically A powered wheelchairs
- ISO 7176-11:2012 Wheelchairs Part 11: Test dummies. A
- A ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
- A ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
- A 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.
- A 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
G. Clinical Test Conclusion
5
No clinical study is included in this submission.
| Elements of
| Comparison | Subject Device(s) | Predicate Device (K182471) | Remark |
|---|---|---|---|
| Manufacturer | Zhejiang Innuovo Rehabilitation | ||
| Devices Co.,Ltd | Tianjin Kepler Vehicle Industry Co. | ||
| Ltd. | -- | ||
| Common or | |||
| Usual name | Scooter | Scooter | Same |
| Model(s) | W3468 | KPL001 | -- |
| 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 | 1075 mm x 510 mm x 930 mm | 1030mm/40.6" x 630mm/24.8" x | |
| 920mm/36.2" | Similar | ||
| 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 | 225 x 65 mm | 190 x 54 mm | Analysis |
| Front Wheels | |||
| Quantity | 2 | 2 | S.E. |
| Rear wheel | |||
| size | 225 x 65 mm | 215 x 70 mm | Analysis |
| Rear Wheels | |||
| Quantity | 2 | 2 | S.E. |
| Ground | |||
| clearance | 85mm(3.3") | 45 mm(1.8") | Analysis |
| Max | |||
| Loading( on | |||
| level ground) | 160kg | 120 kg/265 lbs approx. | Analysis |
| Turn Radius | 1800mm / 70" | 1300 mm(51.2") | Analysis |
| Motor output | 250W | 24 V 180W | Analysis |
| Drive System | Rear Wheel Drive | Rear Wheel Drive | S.E. |
| Brakes | Electromagnetic brake | Electromagnetic brake | S.E. |
| Battery | Lead Acid 12V x 2 (22Ah) | Lead-acid 24V/12AH | S.E. |
| Charger | 24V/2A | 24V/2A | S.E. |
| Max Speed | 6.4 km/h | 6.6 km/h | S.E. |
| Slope Grade | |||
| Ability | 9 degree | 0-12 degree | Analysis |
| Travel | |||
| Distance | 20km / 14 mile (22Ah) | 15 km/9.32 Miles | Analysis |
| Arm Rests | |||
| (Distance | |||
| between | |||
| armrests) | 45 cm | No available data | N/A |
| Controller | PG45A | PG45A | S.E. |
| Time to | |||
| brake | 0.7-1s |