RPL/CPL VERTICAL PLATFORM LIFTS

K091881 · Harmar Summit, LLC · ING · Jul 1, 2009 · Physical Medicine

Device Facts

• Record ID: K091881
• Device Name: RPL/CPL VERTICAL PLATFORM LIFTS
• Applicant: Harmar Summit, LLC
• Product Code: ING · Physical Medicine
• Decision Date: Jul 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3930
• Device Class: Class 2

Indications for Use

The VPL Series Vertical Platform Lift is intended to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

Device Story

AC-powered vertical platform lift; transports wheelchair-bound or ambulatory individuals with mobility disabilities between building levels. RPL model for residential use (600 lb capacity); CPL model for commercial/public use (750 lb capacity). Operated by user or caregiver via controls to move platform vertically. Provides accessibility to multi-level environments; facilitates independent movement for patients with mobility impairments.

Clinical Evidence

Bench testing only. Device conforms to ASME A18.1 (Section 2 and 5) and CSA B44.1 / ASME 17.5 standards.

Technological Characteristics

AC-powered vertical platform lift; electromechanical actuation. RPL model (600 lb capacity); CPL model (750 lb capacity). Conforms to ASME A18.1, Section 2; ASME A18.1, Section 5; and CSA B44.1 / ASME 17.5 standards.

Indications for Use

Indicated for individuals with mobility disabilities, including wheelchair users and ambulatory persons, requiring transport between levels in residential or public facilities.

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 VPL 3100 Vertical Platform Lift (K061514)

Submission Summary (Full Text)

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K091881

Image /page/0/Picture/1 description: The image shows the logo for "Harmar Summit". The logo features a diamond shape on the left, the word "Harmar" above the word "Summit" in a larger font, and a mountain range graphic on the right. The text below the logo is not clear enough to read.

510(k) Premarket Notification

RPL/CPL Vertical Platform Lifts

JUL - 1 2009

# 510(k) SUMMARY

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Summit Harmar, LLC 2075 47th Street Sarasota, Florida 34234 Phone: [phone] Fax: [phone]

Kevin Kaminski Contact Person: Director, Global Sourcing and Logistics

Date Prepared: June 22, 2009

Name of Device

RPL/CPL Vertical Platform Lift

#### Common or Usual Name

Wheelchair Elevator

### Classification Name

Wheelchair Elevator

#### Predicate Device

Bruno VPL 3100 Vertical Platform Lift (K061514)

### Intended Use

The VPL Series Vertical Platform Lift is intended to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

# Device Description

The Harmar Summit, LLC Models RPL and CPL Vertical Platform Lifts are AC powered, patient transport devices designed for use in both residential and commercial applications. Their intended function and use is to transport persons with a mobility

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Image /page/1/Picture/0 description: The image shows the logo for Harmar Summit. The logo includes a diamond shape on the left, the words "Harmar Summit" in bold black letters, and a mountain graphic above the word "Summit". Below the logo, the words "510(k) Premarket Notification" are printed in a smaller font.

RPL/CPL Vertical Platform Lifts

disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

The RPL lift is designed for residential applications and will support a maximum load of 600 lbs. The CPL lift is designed for commercial or public applications, and will support a maximum load of 750 lbs.

# Substantial Equivalence

The Summit Harmar RPL/CPL Vertical Platform Lifts are substantially equivalent to the Bruno VPL 3100 Vertical Platform Lift (K061514).

# Performance Data

The Residential Platform Lift (RPL) is designed to conform with the following standards;

- ASME A18.1, Section 2 Vertical Platform Lifts .
- CSA B44.1 / ASME 17.5 Elevator and Escalator Electrical Equipment .
- ASME A18.1, Section 5 -- Private Residence Vertical Platform Lifts ●

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wings, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

#### Public Health Service-

# JUL -- 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Harmar Summit, LLC % Mr. Kevin Kaminski 2075 47" Street Sarasota, Florida 34234

Re: K091881

Trade/Device Name: Harmar Summit RPL/CPL Vertical Platform Lifts Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: II Product Code: ING Dated: June 24, 2009 Received: June 24, 2009

Dear Mr. Kaminski:

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 Food. Drug, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Kevin Kaminski

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

incerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known): TBD

Device Name: Harmar Summit RPL/CPL Vertical Platform Lifts

Indications for Use:

The intended use of the Harmar Summit RPL/CPL Vertical Platform Lifts is to 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 X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K091881