(60 days)
Not Found
No
The device description and performance studies focus on standard mechanical and electrical components and compliance with mobility scooter standards, with no mention of AI/ML terms or functionalities.
No
The device is described as a transportation vehicle to provide mobility, not to treat or cure a medical condition.
No
A diagnostic device identifies or detects health conditions. This device is a mobility scooter for transportation, not for diagnosis.
No
The device description clearly outlines physical hardware components such as a steel frame, wheels, seat, tiller console, electromagnetic brake, 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 persons. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a transportation vehicle with mechanical and electrical components. There is no mention of reagents, samples (like blood, urine, or tissue), or any process for analyzing biological materials.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body.
- Providing information about a disease, condition, or physiological state.
- Using reagents or test kits.
- Measuring biomarkers or other biological indicators.
The device is clearly a mobility aid, falling under the category of medical devices that assist with physical function.
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: W3331F, has a base with Steal frame, one 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, Third edition 2008-10-01, ISO 7176-5, Second edition 2008-06-01, 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, First edition 1989-08-01, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-21:2009, ISO 7176-25:2013. 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/2 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.
October 17, 2022
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Century Ave., Shanghai 200122, China Shanghai, Shanghai 200122 China
Re: K222495
Trade/Device Name: Mobility Scooter, Model: W3331F Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 18, 2022 Received: August 18, 2022
Dear Jarvis Wu:
We have reviewed vour 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,
Tushar Bansal, PhD Acting 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 Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K222495
Device Name Mobility Scooter, Model: W3331F
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: 2022/8/5
A. Applicant:
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,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:
510Knumber: K222495 Trade Name: Mobility Scooter, Model: W3331F Common Name: Scooter 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: K220206 Device Name: Mobility Scooter Model: W3468A Zhejiang Innuovo Rehabilitation Devices 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: W3331F, has a base with Steal frame, one 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 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:
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A 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 A 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 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.
5
- 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
No clinical study is included in this submission.
H. Comparison with predicate Device
| Table 1 General Comparison | |
|---|---|
| ---------------------------- | -- |
| Elements of
| Comparison | Predicate Device (K220206) | Subject Device (K222495) | Remark |
|---|---|---|---|
| Manufacturer | Zhejiang Innuovo Rehabilitation | ||
| Devices Co.,Ltd | Zhejiang Innuovo Rehabilitation | ||
| Devices Co.,Ltd | Same | ||
| Common or | |||
| Usual name | Scooter | Scooter | Same |
| Model(s) | W3468A | W3331F | ーー |
| 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 500 mm x 920 mm | 940 mm x 500 mm x 840 mm | 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 | 200 x 50 mm | 190 x 55 mm | Analysis |
| Front Wheels | |||
| Quantity | 2 | 1 | Analysis |
| Rear wheel | |||
| size | 200 x 50 mm | 190 x 55 mm | Analysis |
| Rear Wheels | |||
| Quantity | 2 | 2 | S.E. |
| Ground | |||
| clearance | 100mm(3.9") | 45 mm | Analysis |
| Max | |||
| Loading( on | |||
| level ground) | 136kg | 120kg | Analysis |
| Turn Radius | 1350mm(53") | 1200mm | 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 (12Ah or 20Ah) | Lead-acid 12V12Ah*2 | S.E. |
| Charger | 24V/2A | 24V/2A | S.E. |
| Max Speed | 6.4km/h | 6 km/h | S.E. |
| Slope Grade | |||
| Ability | 9 degree | 9 degree | S.E. |
| Travel | |||
| Distance | 14km / 9 Miles (12Ah) | 15 km/9.32 Miles | S.E. |
| Arm Rests | |||
| (Distance | |||
| between | |||
| armrests) | 44 cm | 44-56 cm | Analysis |
| Controller | PG45A | 45 A | Similar |
| Time to | |||
| brake | 0.7-1s |