(65 days)
V-1504 Vertical Platform Lift (K960739)
Not Found
No
The description focuses on mechanical and electrical components, safety standards, and basic control systems. There is no mention of AI, ML, or related concepts.
No
The device is a lift designed for transportation, not for treating or diagnosing medical conditions.
No
Explanation: The device description states its purpose is to mechanically transport persons with mobility disabilities between levels, not to diagnose medical conditions.
No
The device description clearly details a physical, mechanical lift system with hardware components like a drive system, platform, and controls. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "mechanically transport persons with a mobility disability... up and down between levels". This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical lift system with components like a drive system, platform, and controls. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or treatment based on biological analysis.
The Genesis Vertical Platform Lift is a medical device, but it falls under a different category than IVDs. It's a mobility aid designed for physical transportation.
N/A
Intended Use / Indications for Use
The Genesis Vertical Platform Lift is intended to mechanically transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.
Product codes
ING
Device Description
The Genesis Vertical Platform Lift is designed to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility. It can be located within with its own integrated shaftway enclosure, located within a building shaftway or be unenclosed other than guarding around the platform area. It is designed for both indoor and outdoor locations. The Genesis has a capacity of 750 lbs to accommodate a person in a wheelchair and an attendant. The lifting height is up to 14 feet. It is available with a chain hydraulic drive system or an acme screw drive system. Backup systems are available for emergency operation and evacuation. All controls are low-voltage constant pressure. Use may be restricted to authorized persons with key switches located on the control panels. The Genesis is built in accordance with ASME A17.5 Electrical Code for Elevating Devices and the ASME A18.1 Safety Standard for Platform Lifts and Stairway Chairlifts.
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)
V-1504 Vertical Platform Lift (K960739)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
JAN - 7 2004
K033469 Genesis Vertical Platform Lift
3. Summary
..
| Common Device Name: | Elevator, Wheelchair |
|---|---|
| Trade Name: | Genesis Vertical Platform Lift |
| Predicate Device: | V-1504 Vertical Platform Lift (K960739) as |
| manufactured by Services Industriels Savaria Inc. | |
| See the attached product literature. | |
| Device Description: | The Genesis Vertical Platform Lift is designed to |
| transport persons with a mobility disability, either in a | |
| wheelchair or ambulatory, up and down between | |
| levels of a residential or public facility. | |
| It can be located within with its own integrated | |
| shaftway enclosure, located within a building | |
| shaftway or be unenclosed other than guarding | |
| around the platform area. It is designed for both | |
| indoor and outdoor locations. | |
| The Genesis has a capacity of 750 lbs to | |
| accommodate a person in a wheelchair and an | |
| attendant. The lifting height is up to 14 feet. It is | |
| available with a chain hydraulic drive system or an | |
| acme screw drive system. Backup systems are | |
| available for emergency operation and evacuation. | |
| All controls are low-voltage constant pressure. Use | |
| may be restricted to authorized persons with key | |
| switches located on the control panels. | |
| The Genesis is built in accordance with ASME A17.5 | |
| Electrical Code for Elevating Devices and the ASME | |
| A18.1 Safety Standard for Platform Lifts and | |
| Stairway Chairlifts. | |
| See the attached product literature. | |
| Intended Use: | The Genesis Vertical Platform Lift is intended to |
| mechanically transport persons with a mobility | |
| disability, either in a wheelchair or ambulatory, up | |
| and down between levels of a residential or public | |
| facility. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2004
Mr. Norm Cooper Director of Marketing and Customer Relations Garaventa Accessibility 7505 -134A Street Surrey, British Columbia V3W 7B3
Rc: K033469
Trade/Device Name: Genesis Vertical Platform Lift Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: II Product Code: ING Dated: December 4, 2003 Received: December 5, 2003
Dear Mr. Cooper:
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 for use stated in the enatiment date of 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, de rices that have teen that do not require approval of a premarket approval application (PMA). and Cosmeter for (110) warket the device, subject to the general controls provisions of the Act. The 1 ou may, dierely mains 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 (sec above) into either class II (Special Controls) or class III (PMA), it rryour device to such additional controls. Existing major regulations affecting your device can hay be subject to sach additions, 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 docs not mean r rease oc acvised that 1991 one and that your device complies with other requirements of the Act that 1 27 the altern and regulations administered by other Federal agencies. You must or any I edotal statutes and states requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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 - Mr. Norm Cooper
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and h your your 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 n you a 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.
Mark N Millburn
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
Statement of Indications For Use
510(k) Number: K033469
Genesis Vertical Platform Lift Device Name:
Elevator, Wheelchair
Indications for Use:
The Genesis Vertical Platform Lift is intended to mechanically transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mullum
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