← Product Code [ING](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ING) · K983526

# VERTICAL LIFT (K983526)

_Barnes,Richardson & Colburn · ING · Dec 11, 1998 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ING/K983526

## Device Facts

- **Applicant:** Barnes,Richardson & Colburn
- **Product Code:** [ING](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ING.md)
- **Decision Date:** Dec 11, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3930
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Indications for Use

The Vertical Lift is intended to mechanically transport one person in a wheelchair or in a standing position up or down stairs in a private or public facility either indoors or outdoors.

## Device Story

Vertical Platform Lift provides mechanical transport for individuals in wheelchairs or standing positions; facilitates movement between levels in private or public facilities; operates indoors or outdoors; intended for use by individuals requiring mobility assistance; device functions as a mechanical lift platform; provides accessibility for users with limited mobility.

## Technological Characteristics

Mechanical vertical lift platform; designed for indoor/outdoor use; intended for wheelchair or standing transport.

## Regulatory 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.

## Submission Summary (Full Text)

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Food and Brug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Ms. Alyssa Chumnanvech Barnes, Richardson & Colburn Representing Garaventa (Canada) Limited 1225 Eye Street, N.W. Suite 1150 20005 Washington, D.C.

Re: K983526 Vertical Lift Trade Name: Regulatory Class: II Product Code: ING Dated: October 7, 1998 Received: October 8, 1998

Dear Ms. Chumnanvech:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Food, Drug, and Cosmetic Act (Act). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may Existing major be subject to such additional controls. requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Image /page/0/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three wavy lines that form the profile of a human face.

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This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

a M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K983526

Device Name: Vertical Platform Lift

Indications for Use:

The Vertical Lift is intended to mechanically transport one person in a wheelchair or in a The Terreat Blown stairs in a private or public facility either indoors or outdoors.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. § 801.109)

OR

(Division Sign-Off)
Division of General Restorative Dentistry

Division of General Restorativ 510(k) Number

Over-the Counter Use X

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