(126 days)
Not Found
Not Found
No
The summary provides a basic description of a powered wheelchair and does not mention any AI or ML components or capabilities.
No
Explanation: The device, a powered wheelchair, is intended for mobility assistance for individuals restricted to a sitting position. While it provides support for a medical condition, its primary function is mobility aid rather than direct treatment or therapy of a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "intended for medical purposes to provide mobility to persons restricted to a sitting position." This describes a functional aid, not a diagnostic tool that identifies or characterizes a disease or condition.
No
The device description explicitly states "EPW Powered Wheelchair GP-201 Series," which is a hardware device. The summary provides no indication of a software-only component being the subject of the 510(k).
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 sitting position." This describes a device used on a person to assist with a physical function (mobility), not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue for diagnostic purposes.
- Device Description: "EPW Powered Wheelchair GP-201 Series" clearly indicates a mobility aid.
- Lack of IVD Indicators: The document explicitly states "Not Found" for key elements typically associated with IVDs, such as:
- Image processing (often used in IVD analysis)
- AI/DNN/ML (increasingly used in IVD analysis)
- Input Imaging Modality
- Anatomical Site (IVDs analyze specimens, not anatomical sites directly)
- Training/Test Set descriptions (crucial for validating IVD performance)
- Performance Studies and Key Metrics (essential for demonstrating IVD accuracy)
In summary, the intended use and device description clearly place this device in the category of a medical device for mobility assistance, 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 sitting position.
Product codes
ITI
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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/12 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 image of an eagle with three lines representing its wings and head. The eagle is facing to the right.
Public Health Service
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EMG Technology Company, LTD. Ke-Min Jen, Ph.D. c/o Roc Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, Taiwan
Re: K023148
Trade/Device Name: EPW Powered Wheelchair GP-201 Regulation Number: 890.3860 Regulation Name: Wheelchair, powered Regulatory Class: Class II Product Code: ITI Dated: December 13, 2002 Received: December 20, 2002
Dear Dr. Jen:
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
1
Page 2 - Dr. Ke-Min Jen
(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. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely vours,
Mark n Millerson
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
2
Page_1__of__1_
510 (K) NUMBER ( IF KNOW ): __ TBA ___________________________________________________________________________________________________________________________________________ DEVICE NAME: EPW Powered Wheelchair GP-201 Series
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 Division of General Restorative and Neurological Devices
| 710(k) Number | K023148 |
|---|---|
| --------------- | --------- |