(46 days)
Not Found
No
The summary describes a standard powered wheelchair with no mention of AI/ML capabilities or related performance metrics.
No
The device is a powered wheelchair designed to provide mobility and transportation, not to treat or cure a medical condition.
No
The device description indicates it is a powered wheelchair for mobility, not for diagnosis. Its intended use is to provide transportation, and it does not mention any diagnostic capabilities or functions.
No
The device description clearly states it is a "powered wheelchair" with "motors and battery pack," indicating it is a physical hardware device, not software only.
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 human body.
- Device Description: The description details a powered wheelchair for transportation. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in the body
- Diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly a mobility aid, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Zip'r Mantis powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Zip'r Mantis powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into three manageable components (seat set, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
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)
The Zip'r Mantis powered wheelchair complied with the requirements of ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999, ANSI/RESNA ANSI/RESTAT - NOT/20176-6-2001, ANSI/RESNA WC/Vo1.2 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.
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
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Global-FabTech-Wheelchair-(Shanghai) Co., Ltd.
No. 318, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China FAX: +86-21- 6763-2309 TEL: +86-21- 6763-2308
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date of summary was prepared: July 30, 2010
Device
OLT 4 2010
Trade name: Zip'r Mantis powered wheelchair
Common name: Powered wheelchair
Classification name: Powered wheelchair
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3860
Product Code: ITI
Classification: Class II
Predicate devices
CWD01 (K062888) / EMG Technology Co. Ltd.
Zip'r PC (K072224) / Global FabTech Wheelchair (Shanghai) Co., Ltd.
Intend use of device
The Zip'r Mantis powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
Device description
The Zip'r Mantis powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into three manageable components (seat set, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
Summary of non-clinical testing
The Zip'r Mantis powered wheelchair complied with the requirements of ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999, ANSI/RESNA ANSI/RESTAT - NOT/20176-6-2001, ANSI/RESNA WC/Vo1.2 section
1
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
: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.
Substantial equivalence:
The Zip'r Mantis powered wheelchair is substantially equivalent to the CWD01 (K062888) and Zip'r PC (K072224) manufactured by EMG Technology Co. Ltd. and Global FabTech Wheelchair (Shanghai) Co., Ltd., respectively.
There are minor differences in performance specifications of the powered wheelchairs, 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. Therefore, Global FabTech Wheelchair (Shanghai) Co., Ltd. believes that the Zip'r Mantis powered wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.
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'r Mantis powered wheelchair is substantially equivalent to predicate devices as described herein.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
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: K102355
Trade/Device Name: Zip'r Mantis powered wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 1, 2010 Received: September 1, 2010
0CT 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, 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 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
3
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,
for
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number (if known): K102355
Device Name: Zip'r Mantis powered wheelchair
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 801 Subpart D) AND/OR (Part 21 CFR 807 Subpart C) (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
ical, Orthopedie, Restorative Devices
510(k) Number: K102355
(Posted November 13, 2003)