(110 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
No
The device, a folding power chair, is described as providing "optional means of mobility for physically challenged people," which makes it an assistive device for daily living rather than a device intended to treat or ameliorate a disease or condition.
No
The device's intended use is to provide mobility for physically challenged individuals, which is a functional aid, not a diagnostic purpose.
No
The device description explicitly states "PHFW-10 Folding Power Chair," which is a physical hardware device. The summary does not mention any software component that functions as a medical device on its own.
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 an optional means of mobility for physically challenged people." This describes a device used on a person for physical assistance, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: "PHFW-10 Folding Power Chair" clearly describes 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 analyzing specimens)
- AI/DNN/ML (can be used in analyzing complex biological data)
- Input Imaging Modality (relevant for imaging specimens)
- Anatomical Site (IVDs typically analyze specimens from specific sites)
- Patient Age Range (while some IVDs have age ranges, it's not a defining characteristic, but its absence here supports the non-IVD nature)
- Training/Test Set Descriptions, Performance Studies, Key Metrics (these are crucial for demonstrating the analytical and clinical performance of an IVD).
In summary, the intended use and device description point to a mobility device, and the lack of information related to specimen analysis and performance studies confirms it is not an IVD.
N/A
Intended Use / Indications for Use
To provide an optional means of mobility for physically challenged people.
Product codes
ITI
Device Description
PHFW-10 Folding Power Chair
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 a stylized design featuring three abstract shapes resembling birds in flight, arranged in a diagonal line.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ·
NOV 1 9 2002
Pihsiang Machinery Mfg. Co., Ltd. c/o Mr. Chris Tinsley -President Pillar Technology, Inc. 1101 Illinois Street P. O. Box 187 Neodesha, Kansas 66757
Re: K022539
Trade/Device Name: PHFW-10 Folding Power Chair Regulation Number: 890.3860 Regulation Name: Wheelchair, powered Regulatory Class: Class II Product Code: ITI Dated: October 24, 2002 Received: October 28, 2002
Dear Mr. Tinsley:
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.
1
Page 2 -- Mr. Chris Tinsley
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Mark N Mckesson
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
510 (k) Number (if known):
Device Name: _PHFW-10 Folding Power Chair
Indications for Use:
To provide an optional means of mobility for physically challenged people.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
unter Use /
Mark N. Milker
Number K022539
(Optional Format 1-2-96)