(38 days)
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No
The description focuses on mechanical and hydraulic systems, electrical controls, and safety standards, with no mention of AI or ML technologies.
No
The device is a vertical platform lift designed to transport individuals, not to treat a medical condition.
No
Explanation: The V-1504 Vertical Platform Lift is described as a device that mechanically transports an individual in a wheelchair between floors. Its description details its mechanical components and operational features, none of which involve diagnosing medical conditions, analyzing biological samples, or providing information for medical decision-making.
No
The device description clearly details a physical, mechanical lift system with hydraulic components, chains, motors, and steel construction, indicating it is a hardware device, 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 V-1504 Vertical Platform Lift is a mechanical device designed to transport individuals in wheelchairs between floors. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states its purpose is for "mechanically transport an individual in a wheelchair directly between floors". This is a physical function, not a diagnostic one.
Therefore, based on the provided information, the V-1504 Vertical Platform Lift is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The V-1504 Vertical Platform Lift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence or public facility.
Product codes
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Device Description
The V-1504 Vertical Platform Lift is a a lift designed to carry a maximum of one wheelchair and two individuals (500 lb. capacity; 750 lb. optional) directly up and down between floors in a residential or public facility. It is designed for use both inside and outdoors and can be operated either enclosed or unenclosed. The V-1504 is driven by a 2:1 chain hydraulic system, consisting of two #50 high quality roller chains, a cylinder and pump powered by an electric (1.5 hp) motor. The breaking load and stress factor of each chain is 6200 lbs. The lift can be controlled from either end at a key-controlled station or from an on-board panel. All of the controls are of low voltage, incorporate continuous pressure directional buttons, and comply with U.S. ANSI/UL standard 508. The maximum lifting height is 23 feet, and the platform travels at a speed of 25 ft/min. The lift also provides for battery-powered lowering in emergency situations. The platform is constructed of ASTM A366 steel tubing and has an anti-skid surface. The enclosure is made of plexiglass and 0.100" steel tube.
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
K66739
510(k) SUMMARY
| Submitted by: | Barnes, Richardson & Colburn
1225 Eye Street, N.W.
Washington, D.C. 20005 | APR - 1 1996 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | Contact: Ansis M. Helmanis
Tel: (202) 457-0300 | |
| Date Prepared: | February 9, 1996 | |
| Subject Device: | Savaria V-1504 Vertical Platform Lift | |
| Predicate Device: | The National Wheel-O-Vator Co., Inc. Vertical Wheelchair Lift
(K934553). See ATTACHMENT B for product literature. | |
| Subject Product Description: | The V-1504 Vertical Platform Lift is a a lift designed to carry a maximum of
one wheelchair and two individuals (500 lb. capacity; 750 lb. optional)
directly up and down between floors in a residential or public facility. It is
designed for use both inside and outdoors and can be operated either enclosed
or unenclosed. The V-1504 is driven by a 2:1 chain hydraulic system,
consisting of two #50 high quality roller chains, a cylinder and pump
powered by an electric (1.5 hp) motor. The breaking load and stress factor
of each chain is 6200 lbs. | |
| | The lift can be controlled from either end at a key-controlled station or from
an on-board panel. All of the controls are of low voltage, incorporate
continuous pressure directional buttons, and comply with U.S. ANSI/UL
standard 508. | |
| | The maximum lifting height is 23 feet, and the platform travels at a speed of
25 ft/min. The lift also provides for battery-powered lowering in emergency
situations. | |
| | The platform is constructed of ASTM A366 steel tubing and has an anti-skid
surface. The enclosure is made of plexiglass and 0.100" steel tube. For more
technical information see ATTACHMENT A, which also contains
photographs and engineering drawings. | |
1
| Intended Use: | The V-1504 Vertical Platform Lift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence or public facility. |
|---|---|
| Product Comparison: | The V-1504 is substantially equivalent in design and function to National Wheel-O-Vator Co., Inc.'s Vertical Wheelchair Lifts (K934553). Also of steel construction, the Wheel-O-Vator lift uses principally the same design as the V-1504 and accomodates a 550 lb. load (750 lb. capacity optional). It provides a manual operation system similar to that of the V-1504. Moreover, it can be used both indoors and outdoors and can be custom-tailored for varying applications. |
| A comparative table of features for the two devices is set forth on page 4. See ATTACHMENT B for full product labeling for the Wheel-O-Vator. |