(56 days)
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Not Found
No
The device description focuses solely on the physical construction materials of a lift chair and makes no mention of any software, algorithms, or AI/ML related terms.
No.
The description only provides information about the materials and construction of a chair, without any indication of a medical or therapeutic purpose.
No
The device description only details the materials and construction of lift chairs, with no mention of medical a diagnostic function.
No
The device description explicitly states it is constructed of physical materials like wood, foam, fabric, and steel, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses entirely on the physical construction of a lift chair (materials like wood, foam, fabric, and steel). There is no indication that this device is used to examine specimens from the human body (like blood, urine, or tissue) outside of the body.
- Typical IVD characteristics are absent: The provided fields that are typically relevant to IVDs (like intended use for diagnosis, analysis of biological samples, performance metrics related to diagnostic accuracy) are all marked as "Not Found".
A lift chair, as described, is a medical device used for mobility assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
My product is constructed of the same materials, as that of all the lift chair manufacturers I have provided. The chairs consist of oak wood, foam and fabric. The steel frame is constructed of 1"x 1", 16 gauge steel and also 1"x 2" 14 gauge steel.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
SUMMARY OF SAFETY AND EFFECTIVENESS
You will find enclosed literature on Five (5) Lift chair companies already marketing very similar products.
As you will see the motors and switches are all UL listed and CSA approved on each of the five different chairs. I will be using the same motor and switch made by Hubbell Corp.
The lift chair market has been in existence for 25 years, so the product has been fully tested through many cycles.
My product is constructed of the same materials, as that of all the lift chair manufacturers I have provided. The chairs consist of oak wood, foam and fabric. The steel frame is constructed of 1"x 1", 16 gauge steel and also 1"x 2" 14 gauge steel.
The weight capacity of all their units is 300 lbs. which will be the same on mine.
The frame bases on all the units are basically the same width for stability. My frame will be the same.
As you can see my products are actually the same as the products of the five manufacturers enclosed.
As a summary of safety, my products do not raise any safety requirements.
Thank you very much and if you have any questions, my telephone number is (717)-822-8629. My address is as follows:
788 Keating Street Wilkes Barre Twp, PA. 18702