STAODYN MAX PRESET, MODEL 4470

K061516 · Compex Technologies, Inc. · GZJ · Feb 6, 2007 · Neurology

Device Facts

• Record ID: K061516
• Device Name: STAODYN MAX PRESET, MODEL 4470
• Applicant: Compex Technologies, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Feb 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Device Story

Battery-operated (3-AAA) TENS device; delivers electrical pulses through skin to peripheral nerves via two output channels. User selects from 24 preset programs; intensity adjusted via keypad. Features LCD display, on/off/pause button, lead-open detection, and auto-shutoff. Housed in portable plastic case. Used for pain management; output affects nerve signaling to provide relief. Operated by patient or clinician.

Clinical Evidence

No clinical data. Substantial equivalence determined via non-clinical electrical and mechanical bench testing to verify product specifications and validation testing to confirm user needs.

Technological Characteristics

Portable TENS device; molded plastic case; 3-AAA battery powered. Two output channels; symmetric biphasic pulse waveform; max 50V peak on 500 ohms load. Features LCD display and keypad interface. Includes lead-open detection and auto-shutoff functionality.

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain, arthritis-associated pain, and as adjunctive treatment for post-surgical and post-traumatic pain.

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

• American Imex Premier Plus (K032003)

Submission Summary (Full Text)

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KO 615/6

#### 510(k) Summary

# Compex Technologies Inc. Staodyn® Max preset TENS Device

510(k) Number 061516

Date of Summary Preparation:

April 4, 2006

FEB 6 2007

# Submitter/Contact Person:

Carl Beaurline Global Vice President Regulatory Affairs COMPEX Technologies, Inc. 1811 Old Highway 8 New Brighton, MN 55112

Phone: [phone] Fax: [phone]

#### Device Name and Classification:

Trade Name: Staodyn® Max Preset Common Name: Transcutaneous Electrical Nerve Stimulator Classification Name: TENS device Product Code: GZJ , NYN Classification: Class II - 21CFR 882.5890

### Manufacturing Location:

OEM: Tyece, Ltd. Establishment Registration Number: N/A Room 502-3, Po Hing Centre 18 Wang Chiu Road, Kowloon Bay Hong Kong Telephone: [phone] Fax: [phone]

Axelgaard MFG. Co. LTD. Establishment Registration Number: 2025066 329 West Aviation Rd. Fallbrook, CA 92028 Tel: [phone] Fax:

COMPEX Technologies Establishment Registration Number: 2126518 1811 Old Highway 8

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New Brighton, MN 55112 Tel: [phone] Fax: [phone]

#### Predicate Devices:

American Imex Premier Plus -K032003

#### Intended Use:

The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

#### Device Description:

The Staodyn® Max Preset is a Transcutaneous Electrical Nerve Stimulator (TENS) that transmits small electrical pulses through the skin to the underlying peripheral nerves. It is battery operated using 3-AAA batteries and includes two controllable output channels. It generates and delivers electrical impulses whose duration, rate and modulation can be altered by selection of 24 preset programs. The amplitude of the impulses can be increased or decreased with the use of two intensity toggle buttons, one for each output channel. The device has an on/off button that enables the device to be turned on off. In addition, the on/off button can be used to pause a treatment program during use. The stimulator is housed in a molded portable plastic case with a viewable LCD display, accessible keypad, and accessible battery storage compartment.

#### Comparison to predicate:

The Staodyn® Max Preset TENS is substantially equivalent to the IMEX Premier Plus TENS device. The function, performance, and intended use of the Staodyn® Max Preset device is very similar to the Premier Plus. Both systems are designed to relieve pain. The outputs are virtually identical. Each can produce a symmetric biphasic pulse with peak voltage up to 50 Volts on 500 ohms load. Both devices allow the user to select preset programs and set the intensity from 1 to 20 by using a keypad and LCD display of the devices. Both devices have the ability to detect when the lead were open and have Auto shut off feature.

#### Non-clinical Testing:

Verification of the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device includes testing to show the device meets user needs according to marketing requirements.

#### Clinical Testing:

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## COMPEX Technologies. Inc.

The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device does not require clinical testing in order to determine substantial equivalence to the predicate devices.

## Conclusion:

The non-clinical testing demonstrates that the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is safe, effective, and performs as well as the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

. . .

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carl Beaurline Vice President, Regulatory Affairs Compex Technologies, Inc. 1811 Old Highway 8 New Brighton, Minnesota 55112

FEB 6 2007

Re: K061516

Trade/Device Name: Staodyn® Max Preset, Model 4470 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, NYN Dated: December 7, 2006 Received: December 8, 2006

Dear Mr. Beaurline:

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.

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 (1 mr 1), it a 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if

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Page 2 - Mr. Carl Beaurline

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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" (21 CFR 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/industry/support/index.html.

Sincerely yours,

Mar J. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 1 Indication for Use Statement

# Indications for Use

510(k) Number (if known): __ K061516

Device Name: The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device

Indications for Use:

... ... ......................................................................................................................................................................

The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the manager of purf post-surgical and post-traumatic pain.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <b>X</b> | |
|-------------------------------------------------|----------|------------------------------------------------|
| | AND/OR | Over-the-Counter Use<br>(21 CFR 807 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONT(Division Sign-Off IF NEEDED))

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number: 11061511

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