WINCO STRETCHAIR

K110671 · Winco Mfg., LLC · INK · Apr 22, 2011 · Physical Medicine

Device Facts

• Record ID: K110671
• Device Name: WINCO STRETCHAIR
• Applicant: Winco Mfg., LLC
• Product Code: INK · Physical Medicine
• Decision Date: Apr 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3690
• Device Class: Class 2

Intended Use

The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facilities.

Device Story

Battery-powered wheeled stretcher for patient transport and support during examinations within healthcare facilities. Operates via battery-powered linear actuator for backrest/footrest adjustment and hydraulic unit for vertical height adjustment. Used by healthcare staff to move patients between supine and seated positions. Benefits include improved patient mobility and positioning during clinical activities.

Clinical Evidence

Bench testing only. Device meets UL 60601-1 and CAN/CSA C 22.2 electrical safety standards. Upholstery meets CAL 117 flame retardancy requirements.

Technological Characteristics

Battery-powered wheeled stretcher. Features linear actuator for backrest/footrest adjustment and hydraulic unit for vertical height adjustment. Materials include upholstery meeting CAL 117. Electrical safety per UL 60601-1 and CAN/CSA C 22.2.

Indications for Use

Indicated for patient transport within healthcare facilities. Supports patients in supine or seated positions. Weight capacities: S300 (up to 300 lbs), S675 (up to 675 lbs), S999 (up to 1000 lbs).

Regulatory Classification

Identification

A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions).

Special Controls

(1) Appropriate analysis and nonclinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure; (2) Appropriate analysis and nonclinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety; (3) Appropriate analysis and nonclinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device; (4) Appropriate analysis and nonclinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device; (5) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate electromagnetic compatibility and electrical safety; (6) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the skin-contacting components of the device are biocompatible; (7) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented; (8) Appropriate analysis and nonclinical testing must validate that the device components are found to be nonflammable; (9) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the battery in the device performs as intended over the anticipated service life of the device; (10) Adequate labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device in the intended use environment; and (11) Appropriate risk assessment including, but not limited to, evaluating the dimensional limits of the gaps in hospital beds, and mitigation strategy to reduce entrapment.

Predicate Devices

• TransMotion Medical, Inc. Power Drive Chair Model TMM6 (K091043)

Submission Summary (Full Text)

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K110671

# 510(k) SUMMARY

#### Winco Mfg., LLC APR 2 2 2011 Stretchair Powered Wheeled Stretcher

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

Winco, Inc. 5516 Southwest 1st Lane Ocala, Florida 34474

Contact Person: James Ankoviak President and CEO Winco Mfg., LLC 5516 Southwest 1st Lane Ocala, Florida 34474

Date Prepared: February 19, 2011

Name of Device and Name/Address of Sponsor

Winco Stretchair

Winco Mfg., LLC 5516 Southwest 1st Lane Ocala, Florida 34474

# Common or Usual Name

Stretcher

### Classification Name

Stretcher, Wheeled, Powered

#### Predicate Device

TransMotion Medical, Inc. Power Drive Chair Model TMM6 (K091043)

# Intended Use

The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facilities.

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# Technological Characteristics and Substantial Equivalence

# A. Device Description

-

The Winco Mfg., LLC Stretchair is a battery powered device designed for use in healthcare facilities. Its intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility.

The Stretchair can support a patient in either a supine (laying) position or seated position. The Stretchair model S300 is for patients weighing up to 300 lbs, the S675 is for patients weighing up to 675 lbs, and the S999 is for patients weighing up to 1000 lbs.

The product includes a battery powered linear actuator to lower the backrest and raise the footrest simultaneously. It also includes a hydraulic unit for vertical height adjustment.

# B. Substantial Equivalence

The Winco Stretchair is substantially equivalent to the TransMotion Medical, Inc. Power Drive Chair Model TMM6 (K091043)

# Performance Data

The Winco Stretchair has been tested to and meets the requirements of UL 60601-1 and CAN/CSA C 22.2 Electrical Safety Standards. The upholstery used meets the requirements of CAL 117 for Flame Retardancy.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Winco, Inc. % Mr. James Ankoviak President and CEO 5516 Southwest 15t Lane Ocala, Florida 34474

APR 2 2 2 2011

Re: K110671

Trade/Device Name: Winco Stretchair Regulation Number: 21 CFR 890.3690 Regulation Name: Powered wheeled stretcher Regulatory Class: Class II Product Code: INK Dated: February 25, 2011 Received: March 09, 2011

Dear Mr. Ankoviak:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. James Ankoviak

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.

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(211 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm1

Sincerely vours.

Alin B. Dick

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: Winco Stretchair

# Indications for Use:

.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facilities.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of

***_****_*, and the division sign-off) under it.

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110671