(73 days)
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No
The description focuses on mechanical and electrical components, safety features, and compliance with standards, with no mention of AI or ML.
No
The device is a stair lift for transporting individuals, not for treating, diagnosing, or mitigating a disease or condition. Its purpose is mechanical transport, which aligns with an accessibility aid rather than a therapeutic device.
No
The device is a stair platform lift designed to transport individuals in wheelchairs, not to diagnose medical conditions or analyze biological data.
No
The device description clearly outlines a physical, mechanical device with components like a cable/drum unit, steel carriage, platform, and emergency brake, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The ES-125 Stair Platform Lift is a mechanical device designed to transport a person in a wheelchair up and down stairs. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states its purpose is for mechanical transport, not for diagnostic testing.
The information provided about the device's mechanics, safety features, and compliance with standards further confirms it is a mobility aid, not an IVD.
N/A
Intended Use / Indications for Use
The ES-125 Stair Platform Lift is intended to mechanically transport one person in a wheelchair up and down stairs in a private residence or public facility.
Product codes
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Device Description
The ES-125 Stair Platform Lift is an unenclosed stair platform lift designed to carry a wheelchair and its occupant between floors in a residential or public facility. It is accessible via automatic dual access ramps (straight or 90 degree entry) and is driven by a cable/drum unit that incorporates a 3/16" aircraft cable with a breaking load of 4,200 lbs, a deviator pulley, and winding drum. It can be controlled from either end at a key-controlled station or from an on- board, hand-held control panel. The entire carriage unit is designed with ASTM 30 tubular steel, and the fold-away platform contains a non-skid surface. The unit travels at a rated speed of approximately 14 ft/min and possesses a mechanical emergency brake in case of drive cable failure. The lift can be used with stairways at an incline of up to 45 degrees and has a rated carrying load of up to 450 lbs. The power supply is 110 VAC, 1Ph, 60 Hz, 15 amp. The lift complies with ANSI-A17.1 Code specifications regarding elevating devices for the handicapped
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.
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.
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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).
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§ 890.3930 Wheelchair elevator.
(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform lift 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:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.
0
K'COOSX6
510(k) SUMMARY
| Submitted by: | Barnes, Richardson & Colburn
1225 Eye Street, N.W.
Washington, D.C. 20005 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Ansis M. Helmanis
Tel: (202) 457-0300 |
| Date Prepared: | February 9, 1996 |
| Subject Device: | Savaria ES-125 Stair Platform Lift |
| Predicate Device: | Cheney Liberty Wheelchair Lift (K893544). See ATTACHMENT B for product literature. |
| Subject Product Description: | The ES-125 Stair Platform Lift is an unenclosed stair platform lift designed to carry a wheelchair and its occupant between floors in a residential or public facility. It is accessible via automatic dual access ramps (straight or 90 degree entry) and is driven by a cable/drum unit that incorporates a 3/16" aircraft cable with a breaking load of 4,200 lbs, a deviator pulley, and winding drum. It can be controlled from either end at a key-controlled station or from an on- board, hand-held control panel. The entire carriage unit is designed with ASTM 30 tubular steel, and the fold-away platform contains a non-skid surface. The unit travels at a rated speed of approximately 14 ft/min and possesses a mechanical emergency brake in case of drive cable failure. The lift can be used with stairways at an incline of up to 45 degrees and has a rated carrying load of up to 450 lbs. The power supply is 110 VAC, 1Ph, 60 Hz, 15 amp. The lift complies with ANSI-A17.1 Code specifications regarding elevating devices for the handicapped |
| Intended Use: | The ES-125 Stair Platform Lift is intended to mechanically transport one person in a wheelchair up and down stairs in a private residence or public facility. |
| Product Comparison: | The ES-125 is substantially equivalent in design and function to Cheney's Liberty Wheelchair Lifts. Cheney lifts also comply with the ANSI-A17.1 Code and accomodate stairways at an incline of up to 45 degrees. Also fabricated from rectangular steel tubing, the Cheney lift incorporates a platform-type carriage device, which is similarly powered by a self-enclosed, |
APR - 1 1996
1
electric drive unit and controlled by continuous pressure directional buttons with upper and lower limit switches that automatically stop the lift at both ends of travel. In addition, both the ES-125 and the Liberty lift offer obstruction sensor devices and emergency stopping mechanisms and can be custom-tailored for varying architectural design.
For a more technical comparison, refer to the table below. ATTACHMENT B contains product labeling
| Feature | Savaria ES-125 | Cheney Liberty |
|---|---|---|
| ANSI-A17.1 compliance | Yes | Yes |
| Electric motor | Yes | Yes |
| Chain/sprocket drive unit | Yes* | Yes |
| Optional manual operation | Yes | Yes |
| Key-operated station controls | Yes | Yes |
| On-board control with_ | ||
| key switch | Yes | Yes |
| Continuous pressure | ||
| directional controls | Yes | Yes |
| Upper & lower limit | ||
| controls | Yes | Yes |
| Foldable platform | Yes | Yes** |
| Automatic access ramp | Yes | Yes** |
Comparison Table
- Standard on ES-125 Plus model **
Standard on Liberty Wheelchair Lift II model