(44 days)
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No
The description focuses on mechanical and electrical components for elevating a wheelchair seat and does not mention any AI/ML capabilities.
No
The device is designed to elevate a patient in a wheelchair to a greater height, which is a functional enhancement for mobility and access, not a treatment or diagnosis of a disease or condition.
No
The device description indicates that the "Lift Master" is an elevating power seat assembly for wheelchairs, designed to elevate patients to a greater height. Its function is to provide mobility assistance and improve accessibility, not to diagnose a medical condition or disease.
No
The device description clearly outlines physical components such as a ball drive pedestal actuator, aluminum and steel brackets, safety cable, and wiring harness, indicating it is a hardware device with potentially integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to elevate patients in a wheelchair. This is a mechanical function related to mobility and positioning, not the examination of specimens derived from the human body.
- Device Description: The description details mechanical and electrical components (actuator, brackets, wiring harness) and their function in elevating a seat. There is no mention of reagents, calibrators, controls, or any components used for testing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly a mechanical aid for mobility and positioning, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
THE LIFT MASTER ELEVATING POWER SEAT ASSEMBLY DESIGN IS INTENDED FOR USE ON A POWER AND MANUAL WHEELCHAIR. THE LIFT MASTER WILL ELEVATE PATIENTS TO A GREATER HEIGHT THAN THAT OF THE CONVENTIONAL SEAT HEIGHT OF A WHEELCHAIR.
Product codes
890-3860
Device Description
THE LIFT MASTER CONSISTS OF A BALL DRIVE PEDESTAL ACTUATOR WITH A LOAD CAPACITY OF 500 LBS., ALUMINUM AND STEEL BRACKETS, SAFETY CABLE, AND WIRING HARNESS. THE LIFT MASTER BEGINS WITH A SEAT TO FLOOR HEIGHT OF 17 1/2" AND ELEVATES 8" TO AN UPPER LIMIT OF 25 1/2". OTHER RANGES WILL BE AVAILABLE UPON REQUEST. THE SYSTEM HAS A SPEED REDUCTION CAPABILITY WHILE IN THE LIFTED POSITION. THE LIFT MASTER HAS A WEIGHT LIMIT OF 250 LBS. AND A HEIGHT LIMIT OF 6'. OPERATES ON REAR WHEEL DRIVE AND OFFERS CUSTOM SEATING CAPABILITIES.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
NON CLINICAL TESTING: ATTACHMENT.
WHEN DRIVEN IN THE RECOMMENDED POSITION, LIFT MASTER HAS THE SAME STABILITY AS THE WHEELCHAIR MANUFACTURER'S HAD BEFORE INSTALLATION OF THE LIFT MASTER.
WHEN DRIVEN IN THE ELEVATED POSITION ON THE TERRAIN OF 0 DEGREES TO 9 DEGREES, IN THE DESIGNATED DRIVE I POSITION WITH THE MAXIMUM WEIGHT LIMIT OF 250 LBS., THE WHEELCHAIR CAN NOT BE TIPPED OR TURNED OVER AS OUR PHYSICAL TESTING HAS SHOWN UNDER THESE CONDITIONS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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DALVA R. ALEXANDER MECHANICAL APPLICATION DESIGNS, INC. 6819 HWY 90 BLVD., SUITE 680 KATY, TX 77491 (281) 391-8898 (281) 391-5585 FAX
Kg72563
CONTACT: DALVA R. ALEXANDER DATE PREPARED: MARCH 15, 1997 NAME OF DEVICE: LIFT MASTER SYSTEM WHEELCHAIR ELEVATOR TRADE NAME: PROPRIETARY NAME: LIFT MASTER PHYSICAL MEDICINE/POWERED WHEEL-CLASSIFICATION NAME: CHAIR PRODUCT CODE: 890-3860 SUBSTANTIAL EQUIVALENCE: PERMOBIL
THE LIFT MASTER CONSISTS OF A BALL DRIVE DESCRIPTION: PEDESTAL ACTUATOR WITH A LOAD CAPACITY OF 500 LBS., ALUMINUM AND STEEL BRACKETS, SAFETY CABLE, AND WIRING HARNESS. THE LIFT MASTER BEGINS WITH A SEAT TO FLOOR HEIGHT OF 17 1/2" AND ELEVATES 8" TO AN UPPER LIMIT OF 25 1/2". OTHER RANGES WILL BE AVAILABLE UPON REQUEST. THE SYSTEM HAS A SPEED REDUCTION CAPABILITY WHILE IN THE LIFTED POSITION. THE LIFT MASTER HAS A WEIGHT LIMIT OF 250 LBS. AND A HEIGHT LIMIT OF 6'. OPERATES ON REAR WHEEL DRIVE AND OFFERS CUSTOM SEATING CAPABILITIES.
THE LIFT MASTER ELEVATING POWER INTENDED USE: SEAT ASSEMBLY DESIGN IS INTENDED FOR USE ON A POWER AND MANUAL THE LIFT MASTER WILL ELEVATE PATIENTS TO A WHEELCHAIR. GREATER HEIGHT THAN THAT OF THE CONVENTIONAL SEAT HEIGHT OF A WHEELCHAIR.
THE PERMOBIL CHAIRMAN TECHNOLOGICAL CHARACTERISTICS: SYSTEM ELEVATES UP TO 8". PERMOBIL BUILDS THEIR OWN LIFTING TOWER, OPERATES ON FRONT WHEEL DRIVE, AND DOES NOT OFFER SEATING CAPABILITIES. CUSTOM MUST USE THEIR OWN MANUFACTURED SEAT. THE LIFT MASTER ELEVATES UP TO 8". THE LIFT MASTER USES AN ACTUATOR BY MOTION, OPERATES ON REAR WHEEL DRIVE AND OFFERS CUSTOM SEATING CAPABILITIES.
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NON CLINICAL TESTING: ATTACHMENT.
PLEASE REFER TO THE FOLLOWING
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ATTACHMENT 11
LIFT MASTER TESTING
WHEN DRIVEN IN THE RECOMMENDED POSITION, LIFT MASTER HAS THE SAME STABILITY AS THE WHEELCHAIR MANUFACTURER'S HAD BEFORE INSTALLATION OF THE LIFT MASTER.
WHEN DRIVEN IN THE ELEVATED POSITION ON THE TERRAIN OF 0 DEGREES TO 9 DEGREES, IN THE DESIGNATED DRIVE I POSITION WITH THE MAXIMUM WEIGHT LIMIT OF 250 LBS., THE WHEELCHAIR CAN NOT BE TIPPED OR TURNED OVER AS OUR PHYSICAL TESTING HAS SHOWN UNDER THESE CONDITIONS.
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles within its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dalva R. Alexander Chief Executive Officer Mechanical Application Designs, Inc. 6819 Highway 90 Boulevard, Suite 680 Katy, Texas 77494
Re: K972563 Lift Master II Requlatory Class: Product Code: ITI Dated: August 11, 1997 Received: August 15, 1997 AUG 22 1997
Dear Ms. Alexander:
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 reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 requlations.
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Page 2 - Ms. Dalva R. Alexander
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. Whitton, Ph.D.
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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THE LIFT MASTER ELEVATING POWER SEAT ASSEMBLY DESIGN IS INTENDED FOR USE ON A POWER AND MANUAL WHEELCHAIR. THE LIFT MASTER WILL ELEVATE PATIENTS TO A GREATER HEIGHT THAN THAT OF THE CONVENTIONAL SEAT HEIGHT OF A WHEELCHAIR.
Over-the-Counter Use X
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(Division Sign-Off) Division of General Restorative Devices 510(k) Number