(39 days)
Not Found
No
The device description and the absence of mentions of AI, DNN, or ML, along with the type of performance studies conducted (EMC and safety standards), indicate a standard powered wheelchair without AI/ML features.
No
A therapeutic device is one that treats or prevents a disease or condition. This device provides mobility assistance, which addresses a mobility limitation, but does not treat or prevent a disease itself.
No
Explanation: The device description clearly states it is a "Powered Wheelchair" intended "to provide mobility to persons restricted to a seated position." This function is for assistance and mobility, not for diagnosis of a medical condition.
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. It does not mention any components or functions related to testing biological samples or diagnosing conditions.
- 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
- Diagnosing diseases or conditions
- Using reagents or assays
The device is a medical device, but specifically a mobility aid, not an in vitro diagnostic device.
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 F120 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
Kosooll
December 28, 2004
NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (1 FAX: 886-3-53821 TEL: 886-3-5382105 Email: wustis@ms45.hinet.net Homepage: www.wustech.com.tw
510(k) SUMMARY " 46
Submitter's Name: WU'S TECH CO., LTD.
NO, 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN)
Tel: 88
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
WU'S POWERED WHEELCHAIR, MAMBO F 120 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 F120 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:
TAIWAN KINGSTRONG Powered Wheelchair TP01 (K033100)
1
Image /page/1/Picture/0 description: The image shows the text "WU'S TECH CO., LTD.". The text is in a bold, outlined font. The letters are all capitalized and evenly spaced. The text appears to be the name of a company.
NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) TEL: 886-3-5382105 FAX: 886-3-5382191 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
Summary for substantial equivalence comparison:
We can know from the above table that the intended use between the two devices is the same. 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. Especially the electronic systems between two devices are the same suppliers, same specifications, and all passed by the UL certificated, for instance the electronic controller, batteries, recharge, and same cruising range. Besides, the same weight limit, similar maximum speed: ( 6.4 km/hr for the new device and 6.5 km/hr for the predicate device ), similar wheelchair weight: ( 67.3 kgs for the new device and 67 kgs for the predicate device ), similar wheels sizes, same footplates material, and same warranty. The major differences existing are the overall dimension, the size of seat, and the incline degrees is differences between the two devices. Thus the new device is substantially equivalent to the predicate devices in this aspect.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that suggest the head and wings.
Public Health Service
FEB 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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: K050011
Trade/Device Name: WU's Power Wheelchair, Mambo F120 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: February 2, 2005 Received: February 7, 2005
Dear Dr. Ke-Min Jen:
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.
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 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); good manufacturing practice requirements as set 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.
3
Page 2 -- Dr. Ke-Min Jen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 11 you t the Office of Compliance at (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 Manufacturers, International 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,
Sincerely yours,
Mark A. Melkerson
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 F120
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Over-The-Counter Use AND/OR 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 NEEDEI
| 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 | K050011 |