(64 days)
Not Found
No
The description focuses on basic powered wheelchair functionality controlled by hand controls and does not mention any AI/ML features.
No.
The device's intended use is to provide mobility. It does not treat or alleviate a disease, injury, or disability.
No
The device is described as an electric wheelchair intended for mobility, not for diagnosing any medical condition.
No
The device description clearly states it is an "indoor / outdoor electric wheelchair" with a physical 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 test performed on samples taken from the human body.
- Device Description: The description details a powered wheelchair, which is a mobility aid. 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 IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
Therefore, the Taiwan King Strong Powered Wheelchair TP01 is a medical device for mobility, 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
ITI
Device Description
The Taiwan King Strong Powered Wheelchair TP01 is an indoor / outdoor electric wheelchair that is battery operated. It has a base with four-wheeled with a seat and armrests. The movement of the powered wheelchair 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)
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990. EN61000-3-2: 1995. IEC61000-3-3: 1995 (Electrically powered wheelchairs, and their chargers - requirements and test methods)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image shows the text "K033100" in a handwritten style. The characters are bold and slightly distorted, giving them a unique, imperfect appearance. The text is arranged horizontally, with each character clearly distinguishable. The overall impression is that of a quickly written or stylized code or identifier.
September 23, 2003
DEC - 2 2003
TAIWAN KING STRONG CO., LTD.
No. 144, Dong Ming Road, Tachia Chen, Taichung Hsine, Taiwan, 437, ROC Tel: 886-4-26818417 Fax: 886-4-26812686 E-mail: kingstro@ms31.hinet.net
46 510(k) SUMMARY "
Submitter's Name: TAIWAN KING STRONG CO., LTD.
No. 144, Dong Ming Road, Tachia Chen, Taichung Hsine, Taiwan, 437, ROC Tel: 886-4-26818417 Fax: 886-4-26812686
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
Taiwan King Strong Powered Wheelchair TP01 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 Taiwan King Strong Powered Wheelchair TP01 is an indoor / outdoor electric wheelchair that is battery operated. It has a base with four-wheeled with a seat and The movement of the powered wheelchair is controlled by the rider who armrests. 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, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison: COMFORT Powered Wheelchair, Traveller LY-EB103 (K030356)
1
TAIWAN KING STRONG CO., LTD.
No. 144, Dong Ming Road, Tachia Chen, Taichung Hsine, Taiwan, 437, ROC Fax: 886-4-26812686 Tel: 886-4-26818417 E-mail: kingstro@ms31.hinet.net
Summary for substantial equivalence comparison:
The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured. The major differences existing of the two powered wheelchairs are the different controller, and the new device, Taiwan King Strong Powered Wheelchair TP01, is more agile and easy to storage or transportation and the predicate device, COMFORT Powered Wheelchair Traveller LY-EB103. Besides the overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not So the new device is substantially equivalent to the predicate devices safety aspect. 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 2003
Taiwan King Strong Co., Ltd. C/o Ke-Min Jen, Ph.D. ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K033100
K055100
Trade/Device Name: Taiwan King Strong Powered Wheelchair, TP01 Regulation Number: 21 CFR 890.3860 Regulation Name: Powcred wheelchair Regulatory Class: II Product Code: ITI Dated: October 2, 2003 Received: October 20, 2003
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above und have active legally marketed predicate devices marketed in interstate Ior use stated in the enerosure) to regars comment date of the Medical Device Amendments, or to commerce pror to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat have been recuire in asse equire approval of a premarket approval application (PMA). allu Cosmetic Aca (1101) that as novice, subject to the general controls provisions of the Act. The T ou may, mercione, market are as receivements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (600 w/ als. 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 be found interests concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase oc devisou that I be r wasan that your device complies with other requirements of the Act that I 1911 has Intatutes and regulations administered by other Federal agencies. You must or any i catal statures and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 6077; laboring (21 CFR Part 820); and if applicable, the electronic for in the quality by sems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ke-Min Jen, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter witi cation. 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 attire Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark A Millhum
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
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Page 1 of _1
510 (K) NUMBER ( IF KNOW ): _ TBA_ DE VICE NAME: TAIWAN KING STRONG Powered Wheelchair, TP01
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE )
| Prescription Use | OR | Over-The-Counter - Use ✓ |
|---|---|---|
| (Per 21 CFR 801.109 ) | ( Optional Format 1-2-96 ) |
for
(ision Sign-Off)
10(k) N K033100