(39 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 is a power wheelchair designed for mobility, not to treat or alleviate a disease, injury, or disability directly. While it provides assistive functionality for individuals with mobility limitations, it does not fit the definition of a therapeutic device which typically involves active treatment or rehabilitation.
No
The device description clearly states its purpose is to provide mobility. There is no mention of it being used to diagnose any medical condition or characteristic.
No
The device description clearly states it is a "Powered Wheelchair" with a physical base, wheels, seat, hand controls, and battery. This indicates a hardware-based medical device, not a software-only one.
No, 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 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 specific substances (analytes).
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device described is a medical device, specifically a mobility aid, but it does not fit the definition of 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 Genemax Power Wheelchair, PW4 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the 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, controller, and their chargers - requirements and test methods)
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, switches & switching power supplies. Thus the same safety level for the two devices is assured. Besides, the two devices are the same incline, removable arm type, and back upholstery are the same material that also be passed the resistance ignition test by SGS. The major differences existing of the two Power Wheelchairs are the different overall dimension and weight limit between the two devices. The overall appearance and weight differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.
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/1 description: The image shows a logo for "Boneman." The logo is an oval shape with a black background and white text. The text is in a stylized font, and the word "Boneman" is written in all lowercase letters.
NOV 1 2 2004
Genemax Medical Products Industry Corp.
No. 86, Lane 226, Tai-Ming Road, Wu-Jih, Taichung, Taiwan, 414, R.O.C. Tel. 886-4-2335 8500 - Fax: 886-4-2335 6779 e-mail.cenemas@ms31.htmct.net
510(k) SUMMARY " 66
Submitter's Name: Genemax Medical Products Industry Corp. No. 86, Lane 226, Tai-Ming Rd., Wu-Jih Taichung, 414, Taiwan, R.O.C.
Date summary prepared:
September 28, 2004
Device Name:
| Proprietary Name: |
|---|
| Common or Usual Name: |
| Classification Name: |
Genemax Power Wheelchair, PW4 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.
ﮨﮯ
Description of the device:
The Genemax Power Wheelchair, PW4 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the 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.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995. IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison:
TEH LIN Power Wheelchair, TL-320 (K022697)
1
Image /page/1/Picture/0 description: The image shows a black oval shape with the word "Donamax" written in white letters inside. The word is written in a stylized font, with rounded letters. The black oval shape provides a contrasting background for the white text, making it stand out. The overall design appears to be a logo or branding element.
Genemax Medical Products Industry Corp.
No. 86, Lane 226, Tai-Ming Road, Wu-Jih, Taichung, Taiwan, 414, R.O.C. Tel: 886-4-2335 8500 Fax: 886-4-2335 6779 e-mail: genemax@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, switches & switching power supplies. Thus the same safety level for the two devices is assured. Besides, the two devices are the same incline, removable arm type, and back upholstery are the same material that also be passed the resistance ignition test The major differences existing of the two Power Wheelchairs are the by SGS. different overall dimension and weight limit between the two devices. The overall appearance and weight 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 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 a stylized symbol that resembles three overlapping human profiles or abstract shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2004
Genemax Medical Products Industry Corp. C/o Dr. Jen Ke-Min Roc Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K042749
Trade/Device Name: GENEMAX Power Wheelchair, PW4 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 29, 2004 Received: October 4, 2004
Dear Ke-Min:
We have reviewed your Section 510(k) premarket notification of intent to market the device n & neve rowled 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 for doe career in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 2011-12-11 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. Jen Ke-Min
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
sincerely yours,
Mark A. Millhussen
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
K042749 510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: GENEMAX Power Wheelchair, PW4
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 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: K042749