(24 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S Powered Wheelchair MAMBO 36 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.
This is a 510(k) premarket notification for a Powered Wheelchair, which is a Class II medical device. The information provided describes the performance testing and comparison to a predicate device, as opposed to a study on software or AI performance. Therefore, many of the requested categories (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable to this type of submission.
Here's an analysis of the provided text in the context of your request:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria / Test Method | Reported Device Performance (Mambo 36) |
|---|---|
| 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) | The device "passed" these tests. Specifically, the electronic systems use "the same suppliers" as the predicate device and "all passed by the UL certificated," assuring the "same safety level." |
| Strength and fatigue tests (for mainframes) | Mainframes of the two devices (Mambo 36 and Mambo 36X) "all meet the strength and fatigue tests". |
| Resistance ignition test (for back upholstery materials) | Back upholstery materials are the "same fabric and passed the resistance ignition test." |
| Cruising range per charge | 20-30 miles (Improved compared to 10-15 miles for predicate device) |
| Incline angle | 8 degrees (Improved compared to 5 degrees for predicate device) |
| Weight capabilities | 130 kgs (Same as predicate device) |
| Maximum speed | 6.4 km/hr (Same as predicate device) |
Notes on "Acceptance Criteria" and "Reported Performance":
For a physical device like a powered wheelchair, the "acceptance criteria" are generally established by the referenced standards (e.g., ANSI/RESNA WC/Vol.2-1998 for performance, CISPR 11 for EMC). The document states that the new device passed these tests or met the requirements, which implies it met the acceptance criteria implicitly defined by those standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. This submission is for a physical device and references performance testing against established standards for a single device, not a data-driven study with a test set.
- Data Provenance: Not applicable. The testing appears to be physical testing of the device itself, likely performed in Taiwan where the manufacturer is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth as typically understood in AI/software validation (e.g., expert consensus on medical images) is not relevant for the performance testing of a powered wheelchair. The "ground truth" for a wheelchair's performance is adherence to engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication method is mentioned or relevant for this type of device submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a submission for a physical medical device, not an AI or software assistant designed to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the typical sense. The "ground truth" for this device's performance is compliance with established international and national standards for wheelchair safety and performance (e.g., ANSI/RESNA, CISPR, EN, IEC standards). This is determined through physical testing and measurement.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned.
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APR - 2 2007
NO. 225, YUAN-PIER ST. TEL: 886-3-5382105 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
66 510(k) SUMMARY "
Submitter's Name: WU'S TECH CO., LTD.
NO. 225, YUAN-PIER ST., HSIN CHU CITY, 30093, CHINA (TAIWAN)
Date summary prepared:
December 26, 2007
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
WU'S POWERED WHEELCHAIR, MAMBO 36 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 36 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: WU'S Powered Wheelchair MAMBO 36X (K050010)
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NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) TEL: 886-3-5382105 FAX: 886-3-5382191 Email: wustis@ms45.hinet.net Homepage: www.wustech.com.tw
Summary for substantial equivalence comparison:
We can know from the above table that the intended use between the two devices is Mainframes of two devices are fixed. 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 use the same type of armrest, footplate and wheel lock, same seat size, same suspension of cross brace, same weight capabilities 130kgs, same maximum speed 6.4 km/hr, and same warranty. Besides, the back upholstery materials are also the same fabric and passed the resistance ignition test.
Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, motors,and recharge. Thus the same safety level for the two devices is assured.
The major differences exiting the two devices are the cruising range per charge and incline angle. This means the cruising range of the new device is 20-30 miles and the incline angle is 8 degrees, and the predicate device is 10~15 miles and 5 degrees for the incline angle. Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. Thus the new device is substantially equivalent to the predicate devices in this aspect.
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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 features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wu's Tech Co., Ltd. % Republic of China Chinese-European Industrial Research Society Dr. Jen Ke-Min Official Correspondent No. 58, Fu-Chiun Street Hsin-Chu City, 30067, Taiwan Republic of China
APR - 2 2007
Re: K070655
Trade/Device Name: Wu's Power Wheelchair, Mambo 36 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 26, 2007 Received: March 9, 2007
Dear Dr. Ke-Min:
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, Or us and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, l'isting 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 revire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition FFA 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
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Page 2 - Dr. Jen Ke-Min
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.
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 contact 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Mikus
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (K) Number ( If Known ):____ K
Device Name: WU'S POWER WHEELCHAIR, MAMBO 36
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted i a sitting position.
Over-The-Counter Use AND/OR Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(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
§ 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).