(46 days)
To provide mobility to disabled or elderly persons limited to a seated position.
The Zip'r3 and Zip'r3 Xtra scooter are the indoor/outdoor electrical scooter. The design of the scooters is basically similar to other electrical scooters that are already on the market. By providing the electrical scooter that breaks down into three manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
The Zip'r3 and Zip'r3 Xtra scooters are with a 113 kg (250 lbs) weight capacity. They are basic conventional rear wheel drive, rigid frame vehicle that are battery powered. They consist primarily of a welded steel frame, lighting system, a sealed transaxle motor (155W, DC24V) drive system, electromagnetic braking system, electric motor controller (PG S-Drive 45A) and two batteries with an off-board battery charger (2A). They are powered by two 12 volt lead-acid DC batteries with 16 km (10 miles) with 12 AH which maximum speed upto 6.8 km/hr (4.25 mph).
The provided document describes the 510(k) summary for the "Zip'r3 / Zip'r3 Xtra scooter" by Global FabTech Wheelchair (Shanghai) Co., Ltd. This is a medical device submission, and the focus is on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials for novel devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999 | Complied with requirements |
| ANSI/RESNA WC/Vol.1 section 6-1998 / ISO7176-6-2001 | Complied with requirements |
| ANSI/RESNA WC/Vol.2 section 21-1998 / ISO7176-21-2003 | Complied with requirements |
| IEC 61000-4-2-2001 (Electromagnetic Compatibility - ESD) | Complied with requirements |
| IEC 61000-4-3-2008 (Electromagnetic Compatibility - RF Immunity) | Complied with requirements |
| CISPR 11: 2004+A2: 2006 (Industrial, Scientific and Medical RF) | Complied with requirements |
| California Bureau of Home Furnishings 117 Flammability Standards | Complied with requirements |
| Functional Equivalence to Predicate Device (Ruike 3331 K062676) | Substantially equivalent; minor performance differences do not alter intended function/cause new safety/effectiveness questions |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state a sample size for a test set in the way a clinical study would. Instead, it refers to compliance with a series of non-clinical testing standards. These standards typically involve a defined number of units or components subjected to specific tests, but the exact number isn't specified in this summary.
- Data Provenance: The testing was conducted by Global FabTech Wheelchair (Shanghai) Co., Ltd., implying it occurred in China. It is retrospective in the sense that the results are reported after the tests were completed to demonstrate compliance for a premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable (N/A) for this type of submission. The "ground truth" here is compliance with established international and national technical standards (e.g., ISO, ANSI/RESNA, IEC, CISPR, Flammability Standards). These standards themselves define the criteria for success or failure, and the testing is performed by accredited labs or internal quality control departments, not typically "experts" establishing a clinical ground truth in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
- This is not applicable (N/A). The "adjudication" in this context refers to whether the device passed or failed the specified tests within the standards. This is generally a clear pass/fail outcome determined by measurement against the standard, not an expert panel consensus or dispute resolution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC study was not done. This document pertains to a physical medical device (an electrical scooter) and its compliance with engineering and safety standards, not a diagnostic or AI-driven system that would involve human readers interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is compliance with established international and national performance, safety, and electromagnetic compatibility (EMC) standards. These standards (e.g., ISO 7176 series, IEC 61000 series, CISPR 11, California Flammability Standards) define the objective criteria and test methods that the device must meet to be considered safe and effective for its stated intended use.
8. The Sample Size for the Training Set
- This is not applicable (N/A). There is no concept of a "training set" in the context of a 510(k) submission for a physical device demonstrating substantial equivalence through standard compliance. The device itself is the product being tested.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable (N/A) for the same reasons as point 8.
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Global FabTech Wheelchair (Shanghai) Co., Ltd.
No. 318, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China TEL: +86-21- 6763-2308 FAX: +86-21- 6763-2309
510(k) Summary
K102-358
FDA CURH DMC
Received
AUG 1 9 2010
This summary of 510(k) safety and effectiveness information is bei in accordance with requirements of 21 CFR Part 807,92. Date of summary was prepared: July 30, 2010
Device
Trade name: Zip'r3 / Zip'r3 Xtra scooter
Common name: Electrical scooter
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: INI
Classification: Class II
Predicate devices
Ruike 3331 (K062676) / Shanghai Ruike Sports Goods CO., LTD.
Intend use of device
Zip'r3 and Zip'r3 Xtra scooter are intended for the indoor/outdoor electrical scooter that provide transportation for disabled or elderly persons limited to a seated position.
Device description:
The Zip'r3 and Zip'r3 Xtra scooter are the indoor/outdoor electrical scooter. The design of the scooters is basically similar to other electrical scooters that are already on the market. By providing the electrical scooter that breaks down into three manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
The Zip'r3 and Zip'r3 Xtra scooters are with a 113 kg (250 lbs) weight capacity. They are basic conventional rear wheel drive, rigid frame vehicle that are battery powered. They consist primarily of a welded steel frame, lighting system, a sealed transaxle motor (155W, DC24V) drive system, electromagnetic braking system, electric motor controller (PG S-Drive 45A) and two batteries with an off-board battery charger (2A). They are powered by two 12 volt lead-acid DC batteries with 16 km (10 miles) with 12 AH which maximum speed upto 6.8 km/hr (4.25 mph).
l
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Global FabTech Wheelchair (Shanghai) Co., Ltd.
No. 318, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China TEL: +86-21- 6763-2308 - FAX: +86-21- 6763-2309
Summary of non-clinical testing
The Zip'r3 and Zip'r3 Xtra scooter complied with the requirements of ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999, ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001, ANSI/RESNA WC/Vol.2 section 21-1998 / ISO7176-21-2003, IEC 61000-4-2-2001, IEC 61000-4-3-2008, CISPR 11: 2004+A2: 2006, and California Bureau of Home Furnishings 117 Flammability Standards.
Statement of substantial equivalence
The Zip'r3 and Zip'r3 Xtra scooter are substantially equivalent to the Ruike 3331 (K062676) manufactured by Shanghai Ruike Sports Goods CO., LTD.,
There are minor differences in performance specifications of the electrical scooters. these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Global FabTech Wheelchair (Shanghai) Co., Ltd. concludes that, Zip'r3 and Zip'r3 Xtra scooter are substantially equivalent to predicate devices as described herein.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol is a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Global FabTech Wheelchair (Shanghai) Co., Ltd. % Ms. Junnata Chang 16F-2 (16A), No. 462, Sec. 2, ChongDe Road, Beitun District Taichung, China (Taiwan) 406
Re: K102358
Trade/Device Name: Zip' r3 and Zip' r3 Xtra scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 1, 2010 Received: September 1, 2010
4 2010
Dear Ms. Chang:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Junnata Chang
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Zip'r3 and Zip'r3 Xtra scooter
Indications for Use:
To provide mobility to disabled or elderly persons limited to a seated position.
Over-The-Counter Use _ X Prescription Use (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) AND/OIR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Signature
Division (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102358
(Posted November 13, 2003)
§ 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).