(81 days)
Not Found
Not Found
No
The summary describes a power wheelchair with an elevating seat and does not mention any AI or ML capabilities.
No
The device is described as a general purpose utility wheelchair designed for day-to-day living and transportation, allowing users to elevate their seating for better access. Its primary function is mobility and convenience, not to treat, diagnose, mitigate, or prevent a disease or condition, nor to affect the structure or function of the body in a therapeutic manner.
No
The device is described as a "general purpose utility wheelchair" that allows users to elevate their seating, primarily for accessibility purposes. There is no mention of it being used to diagnose any medical conditions or for any type of medical assessment.
No
The device description clearly identifies the device as a "Power Wheelchair," which is a hardware-based medical device. The summary does not mention any software-only components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a general purpose utility wheelchair for day-to-day living and transportation, with the added feature of elevating the user. This is a mobility aid, not a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The description confirms it's an electric elevating power wheelchair.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, this device falls under the category of a medical device, specifically a mobility aid, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These wheelchairs have been designed as general purpose utility wheelchairs, to be used in, and for, the user's day to day living and transportation. They function as any standard power wheelchair does, however they are also designed to allow the user to easily and temporarily elevate the seating system to raise the user to a height slightly greater than that of an average person standing, or any height in between, allowing the user access to high shelves and cabinets, and other things which would be out of reach when seated in a standard wheelchair.
Product codes
IPL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2002 JUL
Mr. David K. Brown Bromac Assistive Technology 15845 Sweetaire Avenue Lancaster, CA 93535
Re: K021165
Trade/Device Name: New Heights Electric Electric Elevating Power Wheelchair Model No. 08 02 series Regulation Number: 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: II Product Code: IPL Dated: April 22, 2002 Received: May 7, 2002
Dear Mr. Brown:
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. David K. Brown
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 your device, please contact the Office of Compliance at (301) 594-4639. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
A. Stypte Rhodes
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): K021165
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stist Prodo
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number_Ko2) ك ك
Prescription Use (Per 21 CFR 801-109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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