(39 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard powered wheelchair and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device provides mobility, which is an assistive function, not a therapeutic one. It does not treat or cure any medical condition.
No
Explanation: The device is described as an electric scooter intended to provide mobility, not to diagnose medical conditions or diseases.
No
The device description clearly states it is an "indoor / outdoor electric scooter" with physical components like a base, wheels, seat, armrests, and hand controls, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a seated position. This is a physical function, not a diagnostic one.
- Device Description: The description details a powered wheelchair/scooter, which is a mobility aid. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the WU'S Powered Wheelchair MAMBO 36X is a medical device, but it falls under the category of a mobility aid, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The WU'S Powered Wheelchair MAMBO 36X is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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)
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
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
ITD K0500
NO. 225. YUAN-PIER ST. TEL: 886-3-5382105 FAX : 886-3-539 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
FEB 1 1 2005
66 510(k) SUMMARY "
Submitter's Name: WU'S TECH CO., LTD.
NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN)
Tel: 88
Date summary prepared:
December 30, 2004
- Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
WU'S POWERED WHEELCHAIR, MAMBO 36X POWERED WHEELCHAIR POWERED WHEELCHAIR, Class II, 21 CFR 890.3860
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The WU'S Powered Wheelchair MAMBO 36X is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison: TEH LIN JUPITER Powered Wheelchair TL-320 (K022697)
1
NO. 225, YUAN-PIER ST., HSIN CHU C TEL: 886-3-5382105 FAX: 886-3-538 Email: wustis@ms45.hinet.net Homepage: www.wustech.com.tw
Summary for substantial equivalence comparison:
The intended use between the two devices is the same. Mainframes of two devices are foldable. Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The suspension of cross brace is the same. The two devices used the same type of armrest. Back upholstery material is also the same fabric. Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, Thus the same safety level for the two devices is assured. batteries, and recharge.
The major differences existing are the overall dimension, the size of seat, weight limit, maximum speed, cruising range, and the incline degrees is differences between the two devices. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo. The logo is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 11 2005
WU's Tech. Co., L.T.D. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial No. 58, Fu- Chiun Street Hsin-Chu City China (Taiwan) ROC 300
Re: K050010
Trade/Device Name: WU's Power Wheelchair, Mambo 36X Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: January 31, 2005 Received: February 3, 2005
Dear Dr. Ke-Min Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for too bearing 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 r ou may, dicterere, mains of the Act include requirements for annual registration, listing of general controls proficturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device n may of basjon to back 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 that I Dr Hoal statutes and regulations administered by other Federal agencies. You must or any I oderal bather and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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.
3
Page 2 - Dr. Ke-Min Jen
This letter will allow you to begin marketing your device as described in your Section 510(k) I his icher will anow you to ough finding of substantial equivalence of your device to a legally prematics notification. " " results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spoolite acrise is (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnaational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division Of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: WU'S POWER WHEELCHAIR, MAMBO 36X
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
AND/OR Over-The-Counter Use Prescription Use _ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number K030010