MERITS E700 PORCE LIFT

K073513 · Merits Health Products Co., Ltd. · ING · Jan 14, 2008 · Physical Medicine

Device Facts

• Record ID: K073513
• Device Name: MERITS E700 PORCE LIFT
• Applicant: Merits Health Products Co., Ltd.
• Product Code: ING · Physical Medicine
• Decision Date: Jan 14, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3930
• Device Class: Class 2

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.

Device Story

Motorized vertical platform lift for private residences; transports individuals with mobility disabilities (wheelchair-bound or ambulatory) between levels. Consists of platform assembly and driving machine case assembly; platform moves along guide rail. Features automatic folding ramp for access and roll-off prevention; safety plate under platform stops motion if obstructed during descent. Operated via continuous-pressure controls on platform panel and call/send stations; lift stops immediately upon switch release. Powered by AC electricity. Provides safe vertical mobility for patients in home environments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Vertical platform lift; AC power source. Construction includes sheet steel plates and guide rails. Driving mechanism utilizes chain sprocket system. Features continuous-pressure control switches, automatic folding ramp, and under-platform safety obstruction sensor. No software or complex algorithms.

Indications for Use

Indicated for individuals with mobility disabilities, including wheelchair users and ambulatory persons, requiring mechanical transport between levels in a private residence.

Regulatory Classification

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. 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).

Special Controls

(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.

Predicate Devices

• Bruno Residential Vertical Platform Lift Model VPL-3100 (K061514)

Submission Summary (Full Text)

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## 510(k) SUMMARY

K073513

- 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

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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 [phone]. 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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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)

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

| 510(k) Number | 073513 |
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