EMPI CONTINUUM

K093324 · Empi · IPF · Mar 5, 2010 · Physical Medicine

Device Facts

• Record ID: K093324
• Device Name: EMPI CONTINUUM
• Applicant: Empi
• Product Code: IPF · Physical Medicine
• Decision Date: Mar 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As an NMES device, indications are for the following conditions: · Retarding or preventing disuse atrophy · Maintaining or increasing range of motion Re-educating muscles · Relaxation of muscle spasms Increasing local blood circulation Prevention of venous thrombosis of the calf muscles immediately after surgery As a TENS device, indications are for the following conditions: Symptomatic relief and management of chronic, intractable pain Adjunctive treatment for post-surgical and post-trauma acute pain Relief of pain associated with arthritis As a Pulsed Current device, indications are for the following conditions: · Reduction of edema (under negative electrode) Reduction of muscle spasm Influencing local blood circulation (under negative electrode) · Retardation or prevention of disuse atrophy Facilitation of voluntary motor function · Maintenance of increase of range of motion As an FES device, the indications for the following condition: Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.

Device Story

Empi Continuum is a multi-modal electrotherapy system providing NMES, TENS, Pulsed Current, and FES. Device delivers electrical stimulation via electrodes applied to patient skin. Operates as a powered muscle stimulator to induce muscle contraction or nerve stimulation for pain management and rehabilitation. Used in clinical settings or by patients under physician prescription. Healthcare providers use device to manage pain, prevent atrophy, reduce edema, and improve gait in paralyzed patients. Output parameters are controlled to achieve therapeutic goals; device provides non-invasive treatment alternative for musculoskeletal and neurological conditions.

Clinical Evidence

Bench testing only. Compliance with UL 60601-1, IEC 60601-1-2, and IEC 60601-2-10 standards demonstrated safety and performance equivalence.

Technological Characteristics

Powered muscle stimulator; electrical stimulation via electrodes. Complies with UL 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-10 (nerve/muscle stimulator safety).

Indications for Use

Indicated for patients requiring NMES for disuse atrophy, range of motion, muscle re-education, spasm relaxation, circulation, or DVT prevention; TENS for chronic intractable pain, post-surgical/trauma acute pain, or arthritis; Pulsed Current for edema, spasm, circulation, atrophy, or motor function; and FES for partially paralyzed patients to improve gait via leg/ankle muscle stimulation.

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.

Predicate Devices

• 300PV Complete Electrotherapy System (K021100)
• Empi SELECT TENS System (K061650)
• REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM (K050046)

Submission Summary (Full Text)

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#### 510 (k) : K093324

MAR - 5 2010

# Section 4: 510(k) Summary per 21 CFR 807.92

SUBMITTER:

Empi Inc. 205 Hwy 22 East Clear Lake, SD 57226

ESTABLISHMENT REGISTRATION: 1721293

CONTACT: Virginia L. Conger, Director of Quality and Regulatory

PROPRIETARY NAME: Empi Continuum

CLASSIFICATION: Class II

PRODUCT CODES: IPF, Powered muscle stimulator GZI, External functional neuromuscular GZJ, Transcutaneous electrical nerve LIH, Interferential current therapy NYN, Stimulator, electrical, transcutaneous, for arthritis

#### REGULATION NUMBER: 21 CFR 890.5850

PANEL:

Physical Medicine

#### Indications for Use:

As an NMES device, indications are for the following conditions:

- · Retarding or preventing disuse atrophy
- · Maintaining or increasing range of motion
- Re-educating muscles
- · Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery

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As a TENS device, indications are for the following conditions:

- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
- As a Pulsed Current device, indications are for the following conditions:
- · Reduction of edema (under negative electrode)
- Reduction of muscle spasm
- Influencing local blood circulation (under negative electrode)
- · Retardation or prevention of disuse atrophy
- Facilitation of voluntary motor function
- · Maintenance of increase of range of motion

As an FES device, the indications for the following condition:

- Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.
## Substantially Equivalent Predicate Devices

| Predicate device(s): | 300PV Complete Electrotherapy System |
|----------------------|--------------------------------------|
| 510(k) number: | K021100 |
| Date: | June 18, 2002 |

Additional Predicate Devices:

| Predicate device(s): | Empi SELECT TENS System |
|----------------------|-------------------------|
| 510(k) number: | K061650 |
| Date: | February 22, 2007 |

| Predicate device(s): | REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR<br>SYSTEM |
|----------------------|------------------------------------------------------------|
| 510(k) number: | K050046 |
| Date: | April 13, 2005 |

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# Declarations of Conformity

The Empi Continuum devices comply with the following FDA recognized Consensus Standards:

- UL 60601-1: 2003, Standards for Medical Equipment Part 1: General . Requirements for Safety, 1st Edition
- IEC 60601-1-2: 2001 +Amendment 1:2004, Medical Electrical Equipment Part . 1 – 2: General requirements for Safety - Collateral Standard, Electromagnetic Compatibility - Requirements and Tests, 2nd Edition
- IEC 60601-2-10: 1987 +Amendment 1:2001, Medical Electrical Equipment -. Part 2-10: Particular Requirements for the safety of nerve and muscle stimulator

# Truthful and Accurate Statement

A statement attesting to the truthfulness and accuracy of the information was included in the premarket submission.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

Empi, Inc. c/o Mr. Jo P. Chiu, MS, MBA Senior Regulatory Affairs Specialist Chattanooga Group 4717 Adams Road Hixson, TN 37343

MAR - 5 2010

Re: K093324

Trade/Device Name: EMPI Continuum Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: February 19, 2010 Received: February 24, 2010

Dear Mr. Chiu:

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.

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#### Page 2 - Mr. Jo P. Chiu, MS, MBA

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 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 (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.

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 (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eile. Then, m k

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: Ko93334

# Device Name: Empi Continuum

# Indications for Use:

As an NMES device, indications are for the following conditions:

- · Retarding or preventing disuse atrophy
- · Maintaining or increasing range of motion
- · Re-educating muscles
- · Relaxation of muscle spasms
- Increasing local blood circulation
- · Prevention of venous thrombosis of the calf muscles immediately after surgery

As a TENS device, indications are for the following conditions:

- · Symptomatic relief and management of chronic, intractable pain
- · Adjunctive treatment for post-surgical and post-trauma acute pain
- · Relief of pain associated with arthritis

As a Pulsed Current device, indications are for the following conditions:

- · Reduction of edema (under negative electrode)
- · Reduction of muscle spasm
- · Influencing local blood circulation (under negative electrode)
- · Retardation or prevention of disuse atrophy
- · Facilitation of voluntary motor function
- · Maintenance of increase of range of motion
- As an FES device, the indications for the following condition:

• Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <div style="display:flex; align-items:center; height:100%;"> <div style="border-bottom: 1px solid black; margin-bottom: 3px; width: 20px;"></div> <div style="margin-left: 5px;">√</div> </div> |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | <div style="border-bottom: 1px solid black; margin-bottom: 3px; width: 20px;"></div> |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tan L. Kawa

(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K093324