ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80

K032954 · Danmeter A/S · IPF · Aug 9, 2004 · Physical Medicine

Device Facts

• Record ID: K032954
• Device Name: ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
• Applicant: Danmeter A/S
• Product Code: IPF · Physical Medicine
• Decision Date: Aug 9, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ELPHA // 500, ELPHA // 1000 This Danmeter device is designed for the symptomatic relief and management of chronic intractable pain and the management of post-surgical pain and post traumatic acute pain. ELPHA // 2000 This Danmeter device is designed for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion. ELPHA II 3000 This Danmeter device is designed for: Symptomatic relief and management of chronic (long-term), intractable pain and the management of post-surgical pain and post traumatic acute pain. Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.

Device Story

Elpha series (Models II 500, 1000, 2000, 3000) are powered muscle stimulators and transcutaneous electrical nerve stimulators (TENS). Devices deliver electrical pulses via electrodes to manage pain or stimulate muscles. Used in clinical or home settings; operated by patients or clinicians. Output affects nerve/muscle tissue to provide pain relief, prevent atrophy, or improve circulation. Elpha II 500/1000 function as TENS for pain; Elpha II 2000 functions as EMS for muscle rehabilitation; Elpha II 3000 combines both TENS and EMS functionalities.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Powered muscle stimulator and TENS device. Electrical stimulation output. Form factor: portable handheld unit. Connectivity: not specified. Sterilization: not specified.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable pain, post-surgical pain, or post-traumatic acute pain (TENS models). Also indicated for muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, and immediate post-surgical calf muscle stimulation to prevent venous thrombosis (EMS models).

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Mr. Hanne Neilsen Quality Manager Danmeter A/S Kildemosevej 13 DK-5000 Odense C Denmark

Re: K032954

K032934
Trade Name: Elpha, Models II 500, II 1000, II 1000, II 2000 and II 3000 Trade Name: - Epine, 21 CFR 890.5850, 21 CFR 882.5890 Regulation Name: 21 CFR 070.5650, 21 OF F 0826 - 1
Regulation Name: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: IPF, GZJ Dated: July 2, 2004 Received: July 8, 2004

Dear Mr. Neilsen:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained institution of the indications
referenced above and have determined the device is substantially interests a for use stated in the enclosure) the arranted the arranted predicate devices marketed in interstate for use stated in the encrosule, to regary manated promote and the Federal Food. Drug commerce prior to May 28, 1970, the chartinent anit of the Federal Food, Drug, devices that have been reclassified in accordance whiles proval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act . The and Cosment Act (Act) that to not require apple the general controls provisions of the Act. The Act. The You may, therefore, market the device, economics for annual registration, listing of general Controls provisions of the free labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in class san If your device is classified (seculority) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controlis. Existing may organ In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 899, Inc. and be found in the Oous of reasts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a succession and other requirements of the Act
that FDA has made a determination that your device complies with other may to that FDA has made a delectimation that your as roo by other Federal agencies. You must or any Federal statutes and regulations administered by of his its increasing increasing and listing (21
comply with all the Act's requirements, including, but not limited to CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 800); go a name (20); and 1f applicable, the electronic (2006); for the electronic (200 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Hanne Neilsen

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin maketing your dovice of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your device premarket notification. The FDA inding of substantial equivation of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the results of the most on 1650 - All any desse note the regulation enti If you desire specific advice for your de necesses in assessment the regulation entitled, the may obtain contact the Office of Complance at [phone] (21CFR Patt 807.97). You may obtain "Misbranding by reference to premarket nonlineauon" (1998) from the Division of Small
other general information on your responsibilities under the Act from number (800) 638-2 other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-Armanain html Manufacturers, International and Consultive Pressonal Prosessor of thinksmaldsmamain.html

Sincerely yours,

Mark A. Milken

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

Enclosure

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## Indications for Use

510(k) Number (if known): K032954

Device Name: ELPHA

Indications for Use:

## ELPHA // 500, ELPHA // 1000

This Danmeter device is designed for the symptomatic relief and management of chronic Trills Danneler device is dosigned for the symption the management of post-surgical pain and post traumatic acute pain.

## ELPHA // 2000

This Danmeter device is designed for the relaxation of muscle spasms, prevention or This Danmeler device to doolghou resing local blood circulation, muscle re-education, retardator of diddod at oping hation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.

## ELPHA II 3000

This Danmeter device is designed for:

- Symptomatic relief and management of chronic (long-term), intractable pain and an . Oymptomation one and the management of post-surgical pain and post traumatic acute pain.
- Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing . local blood circulation, muscle re-education, immediate post-surgical stimulation of lood blood croates to prevent venous thrombosis and maintaining or increasing range of motion.

rt 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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