(71 days)
Not Found
Not Found
No
The device description details a mechanical lift with electronic controls for assisting with sitting and standing. There is no mention of AI or ML in the intended use, device description, or the specific sections checked for AI/ML terms.
No
The device is described as an "aid to daily living tool" that assists individuals with mobility issues in using bathroom facilities. It helps with the physical act of sitting and standing, which are functional tasks, rather than directly treating or diagnosing a medical condition. While it benefits individuals with medical conditions, its primary function is assistive, not therapeutic in nature.
No
The device is a toilet lift designed to assist individuals with mobility issues in accessing bathroom facilities. It does not diagnose medical conditions.
No
The device description clearly details a physical, electromechanical device with components like a seat, lift mechanism, electronic components (manufactured by LINAK), steel frame, and optional wired remote control. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is designed to assist patients with physical limitations in accessing and using toilet facilities. This is a mechanical aid for mobility and daily living.
- Device Description: The description details a mechanical lift with electronic components, seats, and coatings. It describes its function in assisting with sitting and standing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The Aerolet ToiletLift is a medical device, but it falls under the category of assistive devices or durable medical equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Aerolet ToiletLift "K031045" was developed to assist in patient ability to access bathroom facilities due to medical conditions such as the following:
Multiple Sclerosis Muscular Dystrophy Arthritis Inclusion Body Myositis Fredricks Ataxia Parkinsons Syndrome Post-Polio Syndrome Fragile elderly Rehabilitation Leg fractures Hip Replacement Knee Replacement Post-Operative Mobility
Product codes (comma separated list FDA assigned to the subject device)
INO
Device Description
The Aerolet Toilettift is an ergonomically correct aid to daily living tool that replicates the natural sitting and standing process needed for an individual to void. When standing. the end-user leans slightly back onto the raised Aerolet toilet seat, pushes the down button with either hand and waits for the unit to safely bring them over the bowl at a controlled speed. It is adjustable to accommodate any height toilet and can be custom fitted to an individual or multiple user's height.
The Aerolet is also designed to allow the end user to stop on their way up or down allowing perineal cleaning.
Afterwards, the end-user pushes the up button to rise to return to a full standing position enabling the user to walk away without assistance. Those desiring less assistance can either manually decrease the ifft at any point by letting off pressure to the up button. A switch can also be adjusted to decrease maximum lift height. The lift will stop at the preset limit and can not rise higher unless reset.
An optional wired remote hand control is also available. One side note, the remote hand control overides the manual control built info the arm assembly. Other options include a variety of ergonomically correct seats from Pressalit. Soft seats are available in highly durable Gortex materials for durability.
The electronic components are manufactured specifically for the Aerolet by LINAK, Durable Rislan powder coating profects the steels from deterioration from the harsh bathroom environment and corrosive bodily fluids.
The mobile Aerolet is designed for the end user to take it with them when they travel or for use in institutional settings. The Bariatric version lifts consumers up to 880 pounds to enjoy the same benefits as that of the standard unit. This variation is accomplished by adding struts to the standard toiletlift. A larger seat adapts for larger users,
The AEROLET Toiletifft is the standard product comprised of components. It can also be reconfigured with other components to be used as a Shower lift by removing certain electronics out of the product and attachina the unit to the shower wall for stability.
All configurations of the AEROLET ToiletLift comply or exceed Manufacturer Guidelines for the United States of America and the European Union.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 1 0 2003
510K SUMMARY
The Aerolet Toilettift is an ergonomically correct aid to daily living tool that replicates the natural sitting and standing process needed for an individual to void. When standing. the end-user leans slightly back onto the raised Aerolet toilet seat, pushes the down button with either hand and waits for the unit to safely bring them over the bowl at a controlled speed. It is adjustable to accommodate any height toilet and can be custom fitted to an individual or multiple user's height.
The Aerolet is also designed to allow the end user to stop on their way up or down allowing perineal cleaning.
Afterwards, the end-user pushes the up button to rise to return to a full standing position enabling the user to walk away without assistance. Those desiring less assistance can either manually decrease the ifft at any point by letting off pressure to the up button. A switch can also be adjusted to decrease maximum lift height. The lift will stop at the preset limit and can not rise higher unless reset.
An optional wired remote hand control is also available. One side note, the remote hand control overides the manual control built info the arm assembly. Other options include a variety of ergonomically correct seats from Pressalit. Soft seats are available in highly durable Gortex materials for durability.
The electronic components are manufactured specifically for the Aerolet by LINAK, Durable Rislan powder coating profects the steels from deterioration from the harsh bathroom environment and corrosive bodily fluids.
The mobile Aerolet is designed for the end user to take it with them when they travel or for use in institutional settings. The Bariatric version lifts consumers up to 880 pounds to enjoy the same benefits as that of the standard unit. This variation is accomplished by adding struts to the standard toiletlift. A larger seat adapts for larger users,
The AEROLET Toiletifft is the standard product comprised of components. It can also be reconfigured with other components to be used as a Shower lift by removing certain electronics out of the product and attachina the unit to the shower wall for stability.
All configurations of the AEROLET ToiletLift comply or exceed Manufacturer Guidelines for the United States of America and the European Union.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2003
Ms. Stephanie W. Wolfkamp, RN Economic Mobility, Incorporated 6785 Forest Oak Drive Clemmons, North Carolina 27012
Re: K031045
Trade/Device Name: Aerolet ToiletLift, Model AER-01 Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: II Product Code: INO Dated: May 25, 2003 Received: June 2, 2003
Dear Ms. Wolfkamp:
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.
2
Page 2 - Ms. Stephanie W. Wolfkamp, RN
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Sincerely yours,
lo-Mark A. Milkinson
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
3
K031045/A'
ﻟﺪﻳﻨﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ン
: | | ﮯ۔
ﺍ
Image /page/3/Picture/1 description: The image is a close-up, low-resolution black and white photograph. The image is mostly black, with some white areas. The black areas appear to be solid, while the white areas are more textured. There is a horizontal line at the top of the image.
Economic Mobility, Inc
6785 Forest Oak Drive Clemmons, North Carolina 27012 USA 800 342 8801 336 766 7686 www.toiletlift.com info@toiletlift.com
Submitted by Stephanie Wolfkamp, RN
Indications for Usage
Aerolet ToiletLift "K031045" was developed to assist in patient ability to access bathroom facilities due to medical conditions such as the following:
Multiple Sclerosis Muscular Dystrophy Arthritis Inclusion Body Myositis Fredricks Ataxia Parkinsons Syndrome Post-Polio Syndrome Fragile elderly Rehabilitation Leg fractures Hip Replacement Knee Replacement Post-Operative Mobility
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number 031045