(10 days)
None
No
The description focuses on basic mechanical and electrical components and control via hand controls, with no mention of AI/ML terms or functionalities.
No
The device provides mobility, which is an assistive function, not a therapeutic one. It does not treat or cure a medical condition.
No
The device is described as an electric scooter for mobility, and its intended use is to provide mobility. There is no mention of it being used to diagnose any 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 "to provide mobility to persons restricted to a seated position." This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair/scooter, which is a mobility aid. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
Therefore, the WU'S Powered Wheelchair MAMBO 2 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 restricte to a seated position.
Product codes
ITI
Device Description
The WU'S Powered Wheelchair MAMBO 2 is an indoor / outdoor electric scoote 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
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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ko52559
SEP 26 2005
NO. 225, YUAN-PIER ST., HSIN TEL: 886-3-5382105 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
દ 510(k) SUMMARY "
Submitter's Name: WU'S TECH CO., LTD. NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN)
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
September 6, 2005
WU'S POWERED WHEELCHAIR, MAMBO 2 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 restricte to a seated position.
Description of the device:
The WU'S Powered Wheelchair MAMBO 2 is an indoor / outdoor electric scoote 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: WU'S POWERED WHEELCHAIR, MAMBO 3 (K030707)
1
WU'S TECH CO., LTD.
NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) TEL: 886-5-5382105 FAX: 886-5-5382191 Email: wustis@ms45.hinet.net Homepage: www.wustech.com.tw
C.2 COMPARISON SUMMARY
( We place the related information for the predicate device in the following pages. )
We can know from the above table that the intended use between the two devices is Mainframes of two devices are foldable. Mainframes materials of the two the same. devices all meet the strength and fatigue tests and they are similar for the material aspects. The overall dimensions are similar. The two devices used the same type of armrest and the same weight limit. Back upholstery material is also the same fabric. Besides the recharger, batteries, and these critical electrical components are also certified by UL. For the operator's safety aspect they are substantially equivalent.
The maximum speed for the new device is 3.5 mph and 4.0 mph for the predicate device. Lower speed means the new device shall more easily to meet the relevant requirements for the braking time, distance, and dynamic stability for safety considerations.
The major difference existing for new device is more agile and easy to fold for storage or transportation and the predicate device is for general use. The control systems for the two devices are different. It is Dynamic DL for the predicate device and Penny & Giles for the new device. Two of the control systems are all FDA-clearance. CThe safety and performance functions of two systems are assured and validated. They are substantially equivalent. Maximum range per charge is 16 km for the new device, and 40 km for the predicate device. - Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.
Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use the same technological aspects and only minor dimensions and material differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.
2
NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TA FAX: 886-3-5382191 TEL: 886-3-5382105 Homepage: www.wustech.com.tw | Email: wustis@ms45.hinet.net
Summary for substantial equivalence comparison:
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 overall dimensions are similar. The two devices used the same type of armrest and the same weight limit. Back upholstery material is also the same fabric. Besides the recharger, batteries, and these critical electrical components are also certified by UL. For the operator's safety aspect they are substantially equivalent.
The major difference existing for new device is more agile and easy to fold for storage or transportation and the predicate device is for general use. The differences existing are control system, the size of seat, maximum speed, cruising range, and the incline degrees are 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the border of the circle.
Public Health Service
SEP 26 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ROC Chinese-European Industrial Research Society c/o Dr. Jen Ke-Min Wu's Tech Co., LTD No. 58, Fu-Chiun Street Hsin-Chu City, China (Taiwan) 300
Re: K052559
R052357
Trade/Device Name: WU'S POWERED WHEELCHAIR, MAMBO 2 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 6, 2005 Received: September 16, 2005
Dear Dr. Jen Ke-Min:
We have reviewed your Section 510(k) premarket notification of intent to market the device i we nave reviewed your Section 910(x) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tuse stated in the encrosule) to regally manation to the Medical Device American be of the d. Food. Days commerce prior to May 20, 1770, the encenture with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarinians of the Act, T and Cosment Act (Act) that do not require approvince approvisions of the Act. The You may, increrore, market the act include requirements for annual registration, listing of general controls provisions of the 110 lise in a sainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is classified (600 a0070) in. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such additional controller 2. Title 21, Parts 800 to 898. In addition, FDA may be found in the Ooue of Peachasing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oc auvised that 1 Dri- 3 issuates of would in the requirements of the Act that IDA has made a dolorimiations administered by other Federal agencies. You must of any Federal Statutes and regulations and including, but not limited to: registration and listing (21 comply with an the rice srequirements, as and manufacturing practice requirements as set CFR Part 6077, adoming (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Dr. Jen Ke-Min
This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and the may of a lines of a line of a legical statish scrivelence of you This letter will anow you to begin hancemig your article equivalence of your device to a legally premarket notification. The PDA mining of backantal equi
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 If you desire specific advice for your ac not the collection of the regulation entitled, and the may abtain contact the Office of Complanes at (210) =i Ecation" (21CFR Part 807.97). You may obtain "Misbranding by relefence to premarket inclifical virtual the Act from the Division of Small other general information on your responsion.com at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to the seconding http:/ Manufacturers, International and Oomsanhttp://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: WU'S POWERED WHEELCHAIR, MAMBO 2
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDI
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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