8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of

The Securities Exchange Act of 1934

Date of report (Date of earliest event reported):

April 26, 2017

INVACARE CORPORATION

(Exact name of Registrant as specified in its charter)

Ohio	001-15103	95-2680965
(State or other Jurisdiction of Incorporation or Organization)	(Commission File Number)	(I.R.S. Employer Identification Number)

One Invacare Way, P.O. Box 4028, Elyria, Ohio 44036

(Address of principal executive offices, including zip code)

(440) 329-6000

(Registrant’s telephone number, including area code)

———————————————————————————————— 

(Former name, former address and former fiscal year, if changed since last report)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01. Other Events.

On April 26, 2017, Invacare Corporation (the “company”) submitted its written report to the United States Food and Drug Administration (FDA) in accordance with paragraph 5(H) of the consent decree related to its Corporate and Taylor Street facilities in Elyria, Ohio. The "5(H) Report" details the company's actions to correct findings from prior FDA and third-party expert inspections and to ensure that the quality system and controls at the Corporate and Taylor Street facilities have achieved and will sustain compliance with applicable FDA requirements. The company filed the 5(H) Report with FDA following the Agency's recent acceptance of the third expert certification report that was submitted to FDA on February 9, 2016.

Based on the terms of the consent decree, the company expects FDA to initiate inspection of the company's Corporate and Taylor Street facilities within 30 days. The company cannot predict the length of the inspection, nor any remaining work that may be needed to meet FDA's requirements for resuming full operations at the impacted facilities. The company continues to emphasize a culture of quality and compliance at its facilities, and it looks forward to demonstrating its progress to FDA during its inspection.

For more information about the consent decree, refer to the company's Form 10-K and Form 10-Q filings with the Securities and Exchange Commission.

Forward-Looking Statements

This Form 8-K contains forward-looking statements within the meaning of the “Safe Harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are those that describe future outcomes or expectations that are usually identified by words such as “will,” “should,” “could,” “plan,” “intend,” “expect,” “continue,” “forecast,” “believe,” and “anticipate” and include, for example, any statement made regarding the company's future results. Actual results may differ materially as a result of various risks and uncertainties, including any circumstances or developments that might delay or adversely impact FDA's acceptance of the 5(H) report, or FDA's inspection of the company's Corporate and Taylor Street facilities, and those other risks and uncertainties expressed in the cautionary statements and risk factors in the company’s annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. The company may not be able to predict and may have little or no control over many factors or events that may influence its future results and, except as required by law, shall have no obligation to update any forward-looking statements.

Item 9.01.    Financial Statements and Exhibits.

(d) Exhibits.
Exhibit Number	Description of Exhibit
99.1	Press Release, dated April 27, 2017

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	INVACARE CORPORATION
	(Registrant)
Date: April 27, 2017	By:	/s/ Robert K. Gudbranson
	Name:	Robert K. Gudbranson
	Title:	Senior Vice President and Chief Financial Officer

Exhibit Index

Exhibit Number	Description of Exhibit
99.1	Press Release, dated April 27, 2017

EX-99.1

Exhibit 99.1

Investor Inquiries:

Lara Mahoney

440-329-6393

INVACARE REPORTS COMPLETION OF CONSENT DECREE MILESTONES

ELYRIA, Ohio - (April 27, 2017) - Invacare Corporation (NYSE: IVC) today reported it has completed the final two milestones required to initiate the United States Food and Drug Administration’s (FDA) re-inspection of the company's Corporate and Taylor Street facilities, which have been impacted by a consent decree with FDA since December 2012. The re-inspection is an important step before the company may resume full operations at the impacted facilities.

In order to progress to the re-inspection, FDA had to receive a third-party expert certification report confirming the company’s substantial compliance with specified FDA regulatory requirements, as well as the company's own report, as required under paragraph 5(H) of the consent decree, substantiating its compliance. Both of these steps have now been completed. Based on the terms of the consent decree, the company expects FDA’s inspection of the impacted facilities to commence within 30 days.

“Since I arrived at Invacare in 2015, our number one priority has been to build a culture of quality excellence. Our associates have embraced this, and we have made significant progress. We look forward to demonstrating this progress to FDA during its inspection,” said Matthew E. Monaghan, chairman, president and chief executive officer.

Importantly, the company cannot predict the length or outcome of the inspection, nor any remaining work that may be needed to meet FDA's requirements for resuming full operations at the impacted facilities. For more information about the consent decree, refer to the company's Form 10-K and Form 10-Q filings with the Securities and Exchange Commission.

About Invacare Corporation

Invacare Corporation (NYSE: IVC) is a leading manufacturer and distributor in its markets for medical equipment used in non-acute care settings. At its core, the company designs, manufactures and distributes medical devices that help people to move, breathe, rest, and perform essential hygiene. The company provides medical device solutions for congenital (e.g., cerebral palsy, muscular dystrophy, spina bifida), acquired (e.g., stroke, spinal cord injury, traumatic brain injury, post-acute recovery, pressure ulcers) and degenerative (e.g., ALS, multiple sclerosis, chronic obstructive pulmonary disease (COPD), elderly, bariatric) ailments. The company's products are important parts of care for people with a wide range of challenges, from those who are active and heading to work or school each day and may need additional mobility or respiratory support, to those who are cared for in residential care settings, at home, and in rehabilitation centers. The company sells its products principally to home medical equipment providers with retail and e-commerce channels, residential care operators, distributors, and government health services in North America, Europe, and Asia/Pacific. For more information about the company and its products, visit Invacare's website at www.invacare.com.

This press release contains forward-looking statements within the meaning of the “Safe Harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are those that describe future outcomes or expectations that are usually identified by words such as “will,” “should,” “could,”

“plan,” “intend,” “expect,” “continue,” “forecast,” “believe,” and “anticipate” and include, for example, any statement made regarding the company's future results. Actual results may differ materially as a result of various risks and uncertainties, including any circumstances or developments that might delay or adversely impact FDA's acceptance of the company's 5(H) report, or FDA's re-inspection of the company's Corporate and Taylor Street facilities, and those other risks and uncertainties expressed in the cautionary statements and risk factors in the company's annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. The company may not be able to predict and may have little or no control over many factors or events that may influence its future results and, except as required by law, shall have no obligation to update any forward-looking statements.