(167 days)
Not Found
No
The description focuses on electro-mechanical function and safety standards, with no mention of AI or ML.
No
The device aids in rising from a seated to a standing position, which is a supportive function rather than treating or curing a medical condition.
No
Explanation: The device is a lift chair designed to assist individuals with mobility difficulties in rising from a seated to a standing position. Its function is purely mechanical assistance, not diagnosis of any medical condition.
No
The device description clearly states it is an "electro mechanical device" and describes physical components like chairs and actuators, indicating it is a hardware device with electrical and mechanical parts, 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 is to "assist persons who have difficulty rising from a seated position to a standing position." This is a physical assistance function, not a diagnostic one.
- Device Description: The description details an "electro mechanical device" designed to "raise persons from a seated position to a standing position." This aligns with a mobility aid, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information about a person's health. The Winco Power Series Lift Chairs do not perform this function.
N/A
Intended Use / Indications for Use
The intended use of the Winco Inc. Model Power Series Lift Chair is to assist persons who have difficulty rising from a seated position to a standing position.
Product codes
INO
Device Description
The Winco Models Power Series Lift Chairs are electro mechanical devices designed for use in the home or a health care setting. Their intended unnction and use is to raise persons from a seated position to a standing position. They are designed for use by elderly or physically challenged individuals who have difficulty rising to a standing position, when seated.
The Winco Series Lift Chairs consist of two models; the model 696 lift chair and the model 905 lift chair. The model 696 chair is the standard version and is designed to accommodate most users. It is smaller and lighter a vector and 18 905 chair, and has a maximum weight capacity of 300 lbs. The model 905 lift chair is designed for bariatric users. It is wider than the standard 6000 of the chair and has a maximum weight capacity of 600 lbs.
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
home or a health care setting.
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)
The Winco Power Lift Chair actuator has been tested to and meets the requirements of IEC 60601-1
The upholstery used in the Winco Power Lift Chairs meets the requirements of CAL 117 for Flame Retardancy
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3110 Electric positioning chair.
(a)
Identification. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.(b)
Classification. Class II. The electric positioning chair is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable;
(9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and
(10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.
0
510(k) Premarket Notification K080533
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Winco Model Power Series Lift Chair
510(k) SUMMARY
Winco, Inc. Model Power Series Lift Chair
AUG 1 1 2008
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Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Winco, Inc. 5516 Southwest 1st Lane Ocala, Florida 34474
Contact Person: James Ankoviak President and COO Winco, Inc. 5516 Southwest 1st Lanc Ocala, Florida 34474 Phone: (352) 479-3010 Fax: (352) 479-3037 Email: jankoviak@wincomfg.com
Date Prepared: April 15, 2008
Name of Device and Name/Address of Sponsor
Winco Model Power Series Lift Chair
Winco, Inc. 5516 Southwest 1st Lane Ocala, Florida 34474
Common or Usual Name
Lift Chair
Classification Name
Chair, Electric, Positioning
1
Image /page/1/Picture/0 description: The image shows a logo with the text "WIMO" in a stylized font. The text is white and is set against a black oval background. The logo appears to be for a company or organization named WIMO.
Winco Model Power Series Lift Chair
510(k) Premarket Notification K080533
-1-1
Predicate Device
Pride Mobility Model C5 Lift Chairs (K707950)
Intended Use
The intended use of the Winco Inc. Model Power Series Lift Chair is to assist persons who have difficulty rising from a seated position to a standing position.
Technological Characteristics and Substantial Equivalence
A. Device Description
The Winco Models Power Series Lift Chairs are electro mechanical devices designed for use in the home or a health care setting. Their intended unnction and use is to raise persons from a seated position to a standing position. They are designed for use by elderly or physically challenged individuals who have difficulty rising to a standing position, when seated.
The Winco Series Lift Chairs consist of two models; the model 696 lift chair and the model 905 lift chair. The model 696 chair is the standard version and is designed to accommodate most users. It is smaller and lighter a vector and 18 905 chair, and has a maximum weight capacity of 300 lbs. The model 905 lift chair is designed for bariatric users. It is wider than the standard 6000 of the chair and has a maximum weight capacity of 600 lbs.
B. Substantial Equivalence
The Winco, Inc. Model Power Series Lift Chair is substantially equivalent to the Pride Mobility Model C5 Lift Chairs
Performance Data
The Winco Power Lift Chair actuator has been tested to and meets the requirements of IEC 60601-1
The upholstery used in the Winco Power Lift Chairs meets the requirements of CAL 117 for Flame Retardancy
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2008
Winco, Inc. % Mr. James Ankoviak President and COO 5516 Southwest First Lane Ocala, Florida 34474
K080533 Trade/Device Name: Winco Model Power Series Lift Chair Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: April 11, 2008 Received: April 21, 2008
Dear Mr. Ankoviak:
Re:
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, Or is 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 af 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 et 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 100-1000.
3
Page 2 - Mr. James Ankoviak
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K080533
Device Name: Winco Model Power Series Lift Chair
Indications for Use: To assist persons who have difficulty rising from a seated position to a standing position.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Deyice Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page of
510(k) Number /kc80f533