(87 days)
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The document describes a powered wheelchair base and its intended use for individuals with limited mobility. There is no mention of AI or ML technology in the provided text.
No
The device is a powered wheelchair designed for mobility assistance, not for treating or rehabilitating a medical condition. While it aids individuals with various conditions, its primary function is assistive mobility.
No
The Alpha Trac powered wheelchair is described as a mobility aid for individuals with limited mobility due to various conditions, not a device used to identify or diagnose medical conditions. Its purpose is to assist with movement, not to provide diagnostic information.
No
The device description explicitly states "AlphaTrac™ Powered Wheelchair," indicating a physical hardware device. The intended use also describes a "powered wheelchair base," further confirming it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a powered wheelchair base designed to provide mobility assistance to individuals with various physical limitations. This is a physical assistive device, not a diagnostic tool.
- Device Description: The device is described as a "Powered Wheelchair," which is consistent with a mobility aid.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The device's function is to provide physical support and mobility, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Indications for use for the Alpha Trac powered wheelchair base: Alpha Trac design definitions and functional parameters are indicated for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gail patterns. Also due to the specific driving control supplied by the TransAxle persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the AlphaTrac with no modifications. This usage would be indicated but not limited to the following types of injury's: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Parkinson's Amputees Brown Sequard's Syndrome and resultant paralysis Severe Arthritics (RA) (OA) Multiple Sclerosis (MS) Amyotrophic Lateral Sclerosis (ALS) Huntington's Corea Traumatic Brain Injury (TBI) Anoxic Encephalopathy Anoxia Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal weakness Quadriparesis Paranaresis Cercural vascular Accident (C
§ 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).
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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 stylized eagle or bird-like figure with three curved lines forming its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
Mr. Thomas E. Finch III Vice President Teftec Corporation 6929 Old Spring Branch Road Spring Branch, Texas 78070
Re: к982815 AlphaTrac™ Powered Wheelchair Trade Name: Regulatory Class: II Product Code: ITI Dated: August 6, 1998 Received: August 7, 1998
Dear Mr. Finch:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Thomas E. Finch III
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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· 510 (k) NUMBER (IF KNOWN) :
DEVICE NAME:
AlphaTrac-Powered Wheelchair
INDICATIONS FOR USE:
Indications for use for the Alpha Trac powered wheelchair base:
Alpha Trac design definitions and functional parameters are indicated for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gail patterns. Also due to the specific driving control supplied by the TransAxle persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the AlphaTrac with no modifications.
This usage would be indicated but not limited to the following types of injury's: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Parkinson's Amputees Brown Sequard's Syndrome and resultant paralysis Severe Arthritics (RA) (OA) Multiple Sclerosis (MS) Amyotrophic Lateral Sclerosis (ALS) Huntington's Corea Traumatic Brain Injury (TBI) Anoxic Encephalopathy Anoxia Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal weakness Quadriparesis Paranaresis Cercural vascular Accident (C