INFINITY ELECTROTHERAPY SYSTEM

K042057 · Empi · LIH · Dec 17, 2004 · Neurology

Device Facts

• Record ID: K042057
• Device Name: INFINITY ELECTROTHERAPY SYSTEM
• Applicant: Empi
• Product Code: LIH · Neurology
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Infinity is a multi-function electrotherapy device with various treatment modes that allow for conventional interferential and premodulated interferential current stimulation (IFS) and is indicated for the following conditions: Symptomatic relief of acute pain . Symptomatic relief and management of chronic intractable pain . Symptomatic treatment for post-surgical and post-trauma acute pain

Device Story

Infinity Electrotherapy System; multi-function device providing two channels of conventional and premodulated interferential current stimulation (IFS). Device generates balanced asymmetrical and symmetrical biphasic waveforms; max output 50 mA/500 V per channel. Features include timed therapy sessions, continuous stimulation, adjustable pulse rates, and seven pre-set/custom programs. Clinician uses lock option to control treatment regimens and intensity; patient uses pause function. Device used in clinical settings to provide symptomatic pain relief. Output intensity resets to zero upon restart after pause. Benefits include management of acute and chronic pain conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technical comparison and design similarity to predicate devices.

Technological Characteristics

Two-channel electrotherapy system; provides interferential and premodulated interferential current stimulation. Features dedicated intensity controls, timed therapy, and adjustable pulse rates. Waveforms: balanced asymmetrical and symmetrical biphasic. Max output: 50 mA/500 V per channel. Includes seven programs (three conventional IF, three premodulated IF, one custom).

Indications for Use

Indicated for symptomatic relief of acute pain, chronic intractable pain, and post-surgical or post-traumatic acute pain in patients requiring electrotherapy.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Empi 300 PV (K021100)
• Ryan Telemedicine (K030254)

Submission Summary (Full Text)

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K042057

# DEC 17 2004

## 510(k) Summary for Infinity Electrotherapy System

- 1. SPONSOR
Empi 599 Cardigan Road St. Paul, Minnesota 55126-4099

Contact Person: Kathleen Schmitt [phone] Telephone:

Date Prepared: December 13, 2004

#### 2. DEVICE NAME

| Proprietary Name: | Infinity Electrotherapy System |
|-----------------------|-----------------------------------------------------------------|
| Common/Usual Name: | Electrical Muscle and Nerve Stimulator |
| Classification Names: | Powered Muscle Stimulator, Interferential Current<br>Stimulator |

#### 3. PREDICATE DEVICES

| Empi 300 PV | K021100 |
|-------------------|---------|
| Ryan Telemedicine | K030254 |

#### 4. INTENDED USE

The Infinity is a multi-function electrotherapy device with various treatment modes that allow for conventional interferential and premodulated interferential current stimulation (IFS) and is indicated for the following conditions:

- Symptomatic relief of acute pain .
- . Symptomatic relief and management of chronic intractable pain
- . Symptomatic treatment for post-surgical and post-trauma acute pain

December 13, 2004

510(k) Summary · Page E-1

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#### 5. DEVICE DESCRIPTION

The Infinity is a multifunction electrotherapy device with various treatment modes that allows for interferential current stimulation (IFS) and premodulated interferential current stimulation. It has the ability to provide two channels of conventional interferential and premodulated interferential stimulation. The Infinity offers the following features:

- . Channels 1 and 2, which are multi-purpose outputs (IF and PM IF)
- . Each channel has a dedicated intensity control
- . Maximum stimulation of 50 mA/500 V from each channel
- . Timed therapy sessions
- . Continuous stimulation
- . Adjustable pulse rates
- Balanced asymmetrical and symmetrical biphasic waveforms
- . Seven programs: three for conventional interferential, three for premodulated interferential and one for custom stimulation
- . Lock option for clinician to control treatment regimens and stimulus intensity
- . Pause function for patient to pause stimulation. During pause, the timer will not count down if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters but a stimulus intensity of zero

#### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The Infinity is an extension of the 300 PV and is similar in design and functions. Both offer multiple treatment programs, and the user can either choose one or more of these options or customize the treatment regimen within the available parameter ranges. The Infinity is a two-channel system that includes conventional and premodulated interferential stimulation whereas the 300 PV is a four-channel system. Additionally, it is not indicated for NMES, for FES or TENS since it does not include the accessories for FES, nor does it include the waveforms for FES and TENS. The conclusion of this technical comparison is that the Empi Infinity is substantially equivalent to the predicate devices for the indications specified.

December 13, 2004

510(k) Summary · Page E-2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Empi, Inc. C/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. Staff Consultant 49 Plain Street North Attleboro, Massachusetts 02760

Re: K042057

Trade/Device Name: Infinity Electrotherapy System Device Name: Interferential current therapy Regulatory Class: Unclassified Product Code: LIH Dated: December 8, 2004 Received: December 9, 2004

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regard) the enactment date of the Medical Device Amendments, or to conniner of the May 20, 1977, ... . ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. de vices that have been form do not require approval of a premarket approval application (PMA). and Costiette Ace (110.) that as nevice, subject to the general controls provisions of the Act. The I ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provision 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 such additional controls. Existing major regulations affecting your device can thay be fabyer to deen 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 r toals of a not a 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 of uny I oderal battler and streequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It Fart 007), assems (QS) 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 - Ms. Mary McNamara-Cullinane, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Mark H. Melkerson

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):

Device Name: Infinity Electrotherapy System

Indications for Use:

The Infinity is a multi-function electrotherapy device with various treatment modes that The Internety is a thank interferential and premodulated interferential current stimulation (IFS) and is indicated for the following conditions:

- Symptomatic relief of acute pain .
- Symptomatic relief and management of chronic intractable pain .
- Symptomatic relief for post-surgical and post-traumatic acute pain .

Prescription Use __ X ____________________________________________________________________________________________________________________________________________________________________________ (Part 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milburn

E 36 Super Division of General. Restorative. and Neurological Devices

**510(k) Number** K042057