(39 days)
Not Found
No
The description focuses on standard powered wheelchair features and control mechanisms, with no mention of AI or ML.
No
The device provides mobility to persons restricted to a sitting position, which is a supportive function, not a therapeutic treatment for a disease or condition.
No
Explanation: The device description clearly states it is a power wheelchair intended for mobility, not for diagnosing any medical condition.
No
The device description clearly states it is a "Powered Wheelchair" with a physical base, wheels, seat, hand controls, and battery, 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 sitting position. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a power wheelchair, 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: There are no mentions of:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or treatment based on biological analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This power wheelchair does not fit that description.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricts to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Genemax Power Wheelchair, PW3 is an indoor / outdoor Powered Wheelchai 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)
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
NOV 12 2004
Image /page/0/Picture/2 description: The image shows a logo with the word "donemax" in white letters against a black oval background. The word "donemax" is written in a stylized font, with the letters slightly rounded. The black oval shape provides a contrasting backdrop that makes the text stand out. The logo has a simple and clean design.
Genemax Medical Products Industry Corp.
No. 86, Lane 226, Tai-Ming Road, Wu-Jih, Taichung, Taiwan, 414, R.O.C. Tel: 886-4-2335 85(K) Fax: 886-4-2335 6779 e-mail: genemax(@ms3).hinet.net
દર 510(k) SUMMARY "
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:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
Genemax Power Wheelchair, PW3 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 restricts to a seated position.
Description of the device:
The Genemax Power Wheelchair, PW3 is an indoor / outdoor Powered Wheelchai 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)
September 28, 2004
1
Image /page/1/Picture/0 description: The image shows a black oval with the word "Donamax" written in white letters inside. The letters are stylized and slightly rounded, giving them a cartoonish appearance. The black oval provides a contrasting background that makes the word stand out.
Genemax Medical Products Industry Corp.
No. 86. Lane 226. Tui-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
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 the same. The batteries used are the same supplier and similar U1 type. The control systems for the two devices are used from same brand: Penny & Giles. The recharge for the two devices are also used the same supplier, and the chargers are also certified by Besides, the foldable frame, removable armrest type, same cruising range, same UL. footplates, same incline, and back upholstery are the same material that also be passed the resistance ignition test by SGS.
The weight capabilities for the two devices are different, and there is 22.1 pounds difference, between 264.6 pounds and 242.5 pounds. This means the new device can bear more weight than the predicate device. I The safety levels of the two devices are the same when operating the devices on the same 12 degrees inclines. They are substantially equivalent.
The maximum speed for the new device is 5 mph and 2.62 mph for the predicate Higher speed means the new device shall meet relevant requirements for the device. braking time, distance, and dynamic stability for safety considerations. The different maximum speeds do not lead any safety considerations and they are substantially equivalent in this aspect.
To sum up the mainly different of the two devices are only appearance dimensions, i.e., the overall dimensions, the size of wheels, seat dimensions, weight limit, and maximum speed. For the regular operator, these differences for the two devices do not lead to any performance differences, and 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
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 featuring three abstract shapes that resemble human figures or waves, arranged in a dynamic, flowing pattern.
Public Health Service
NOV 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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: K042748
Trade/Device Name: GENEMAX Power Wheelchair, PW3 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 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, 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,
Mark A. Millam
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
K042748 510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: GENEMAX Power Wheelchair, PW3
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)
Concurence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of
510(k) Number K042748