(31 days)
Not Found
No
The description focuses on mechanical and electrical components and control systems, with no mention of AI or ML capabilities.
No.
The device is a wheelchair elevator designed for mechanical transport, not for treating or preventing a medical condition.
No
The device description and intended use clearly state that it is a mechanical lift for transporting individuals, not for diagnosing conditions.
No
The device description clearly outlines physical components such as a platform assembly, driving machine case assembly, guide rail, sheet steel plates, automatic folding ramp, safety plate, and control devices, indicating it is a hardware device with some control software.
Based on the provided information, the Merits E700 Porch Lift System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to mechanically transport individuals with mobility disabilities. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical lift system with a platform, motor, controls, and safety features. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing information for diagnosis, monitoring, or treatment decisions based on biological data.
The device is clearly a medical device intended for mobility assistance, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Merits E700 Porch Lift System is a wheelchair elevator, also commonly known as a vertical platform lift. It is a motorized device intended to mechanically transport an individual with mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence.
Product codes (comma separated list FDA assigned to the subject device)
ING
Device Description
The Merits E700 Porch Lift basically consists of a platform assembly and a driving machine case assembly. The platform assembly vertically moves along a guide rail welded to the driving machine case assembly. The sides of the platform assembly are guarded by sheet steel plates. The lower landing side of the platform is equipped with an automatic folding ramp to not only offer easy access to the platform but also to prevent the mobility device rolling off the edges. The ramp will be automatically folded up as the lift begins to move upward and remain in elevated position until the platform returns to the lower landing. The underside of the platform is equipped with a safety plate to stop the motion when the platform is obstructed in the downward direction. The driving machine case assembly contains all necessary operation systems in the case. The operation of the lift is controlled by the platform operating panel and the call/send controls. These control devices are designed by means of continuous pressure type, which stop the lift immediately when the switch is released. The Merits E700 Porch Lift is using AC power as its power source.
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
private residence
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)
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
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.
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
§ 890.3930 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
510(k) SUMMARY
- Trade/Proprietary Name: Merits E700 Porch Lift 9.1
- Common/Usual Name: Vertical Platform Lift 9.2
- Classification Name: Wheelchair Elevator 9.3
JAN1 4 2008
- Comparison to Currently Marketed Devices 9.4
The Merits E700 Porch Lift is substantially equivalent to the Bruno Residential Vertical Platform Lift Model VPL-3100 (K061514)
તે રે Device Description
The Merits E700 Porch Lift basically consists of a platform assembly and a driving machine case assembly. The platform assembly vertically moves along a guide rail welded to the driving machine case assembly. The sides of the platform assembly are guarded by sheet steel plates. The lower landing side of the platform is equipped with an automatic folding ramp to not only offer easy access to the platform but also to prevent the mobility device rolling off the edges. The ramp will be automatically folded up as the lift begins to move upward and remain in elevated position until the platform returns to the lower landing. The underside of the platform is equipped with a safety plate to stop the motion when the platform is obstructed in the downward direction. The driving machine case assembly contains all necessary operation systems in the case. The operation of the lift is controlled by the platform operating panel and the call/send controls. These control devices are designed by means of continuous pressure type, which stop the lift immediately when the switch is released. The Merits E700 Porch Lift is using AC power as its power source.
તે. વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. તેમજૂરી તેમ જ દૂધની ડેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત Intended use
The Merits E700 Porch Lift System is a wheelchair elevator, also commonly known as a vertical platform lift. It is a motorized device intended to mechanically transport an individual with mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence.
9.7 Technological Characteristics
Merits E700 Porch Lift is equivalent in functions to the legally marketed predicate device. Although the two lifts are using different driving means for operation, the utilization of chain sprocket by Merits E700 Porch Lift is still reliable to satisfy the driving needs. The application of chain sprocket is wellestablished and has been extensively used by other legally marketed products. The driving means of chain sprocket has no major technological difference comparing to that of screw. Moreover, the difference of the suspension and braking of the two lifts does not affect their functional effectiveness. Unlike
1
the screw means adopted by the Bruno's lift, Merits E700 Porch Lift fulfills the functions by means of chains. The technology of chains is mature enough to provide the reliable method to satisfy the specific functional requirements.
9.8 Performance Data
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
ਹੇਂ ਹੋ Conclusion
Based on the design, performance specifications, testing, and intended use, the Merits E700 Porch Lift is substantially equivalent to the legally marketed device, Bruno Residential Vertical Platform Lift Model VPL-3100 (K061514)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Merits Health Products Co., LTD. % Mr. Steve Chao No. 9, Rd. 36, Taichung Industrial Park Taichung City China (Taiwan) 40768
Re: K073513
Trade/Device Name: Merits E700 Porch Lift Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: II Product Code: ING Dated: December 10, 2007 Received: December 14, 2007
Dear Mr. Chao:
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 Foond, Or ug, 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.
'JAN 1 4 2008
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 devire 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.
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Page 2 - Mr. Steve Chao
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number:
Device Name: Merits E700 Porch Lift
Indications For Use:
The Merits E700 Porch Lift System is a wheelchair elevator, also commonly known as a vertical platform lift. It is a motorized device intended to mechanically transport an individual with mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence.
(Division Sign-Qff) Division of General, Restorative, and Neurological Devices
510(k) Number_
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 073513 |
|---|---|
| --------------- | -------- |