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): December 30, 2013

ELECTROMED, INC.

(Exact Name of Registrant as Specified in Its Charter)

Minnesota	001-34839	41-1732920
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

500 Sixth Avenue NW
New Prague, MN 56071

(Address of Principal Executive Offices)(Zip Code)

(952) 758-9299

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

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:

☐	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))

Item 8.01 Other Events.

On December 30, 2013, Electromed, Inc. (the “Company”) issued a press release announcing that it had received notification from the U.S. Food and Drug Administration that the Company’s next generation SmartVest^® Airway Clearance System, the model SQL^TM had been cleared to market. A copy of the Company’s press release is attached as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Exhibits.

(a)	Financial statements: None.
(b)	Pro forma financial information: None.
(c)	Shell company transactions: None.
(d)	Exhibits:
	99.1	Press Release dated December 30, 2013.

SIGNATURES

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

	Electromed, Inc.
Date: December 30, 2013	By	/s/ Jeremy Brock
	Name:	Jeremy Brock
	Title:	Chief Financial Officer

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

ELECTROMED, INC.

EXHIBIT INDEX TO FORM 8-K

Date of Report:	Commission File No.:
December 30, 2013	001-34839

Exhibit
Number	Description
99.1	Press Release dated December 30, 2013.

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

Contact:

Kelly Lunder

Manager of Marketing & Communications

klunder@electromed.com

952-758-0382

Electromed, Inc. receives FDA Market Clearance for the SmartVest^® SQL^TM

New Prague, Minnesota – December 30, 2013 – Electromed, Inc. (NYSE MKT: ELMD), a global medical device company, today announced it has received notification from the U.S. Food and Drug Administration that its next generation SmartVest^® Airway Clearance System, the model SQL^TM has been cleared to market.

“SQL solidifies Electromed’s innovation leadership by offering a device that is smaller, quieter, and lighter than our previous versions,” said Kathleen Skarvan, Chief Executive Officer. “We designed the SQL to stand apart from the competition with features that our patients and clinicians were asking for. They talked, and we listened.” In addition to being significantly smaller, quieter, and lighter than our previous versions, some of the features include enhanced ramping, an enhanced pause feature and more user-friendly graphics.

The model SQL is an electrically powered precursor device designed to deliver high frequency chest wall oscillation (HFCWO) to promote airway clearance, improve bronchial drainage and enhance mucus transport under the order of a physician’s prescription. It is prescribed to patients with a wide range of pulmonary-related health conditions including bronchiectasis, chronic obstructive pulmonary disease (COPD), cystic fibrosis, muscular dystrophy, and cerebral palsy. HFCWO has been demonstrated to reduce lung infections and reduce health care costs associated with recurrent pneumonias, antibiotic use, and hospital stays. In addition to the innovative SQL generator, the system boasts a lightweight soft-fabric garment with several patented features.

“We believe we have the most comfortable and easy-to-use system among leading HFCWO devices, which leads to therapy adherence and better patient outcomes,” Skarvan added.

Electromed anticipates that the model SQL will be available to the U.S. market within the next 60 days.

About Electromed, Inc.

Electromed, Inc. manufactures, markets, and sells products that provide airway clearance therapy, including the SmartVest^® Airway Clearance System, to patients with compromised pulmonary function. Further information about the Company can be found at www.electromed.com, or call 800-462-1045.

Cautionary Statements

Certain statements found in this release may constitute forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect the speaker’s current views with respect to future events and financial performance and include any statement that does not directly relate to a current or historical fact. Forward-looking statements can generally be identified by the words “believe,” “expect,” “anticipate” or “intend” or similar words. Forward-looking statements made in this release include the Company’s expectations regarding the availability of the model SQL in the U.S. market. Forward-looking statements cannot be guaranteed and actual results may vary materially due to the uncertainties and risks, known and unknown, associated with such statements. Examples of risks and uncertainties for Electromed include, but are not limited to, delays in the production or shipment of our products, the reluctance of physicians or other healthcare providers to accept a new product, the impact of emerging and existing competitors, and the effectiveness of our sales and marketing and cost control initiatives, as well as other factors described from time to time in our reports to the Securities and Exchange Commission (including our Annual Report on Form 10-K). Investors should not consider any list of such factors to be an exhaustive statement of all of the risks, uncertainties or potentially inaccurate assumptions investors should take into account when making investment decisions. Shareholders and other readers should not place undue reliance on “forward-looking statements,” as such statements speak only as of the date of this release.

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