FENZIAN TREATMENT SYSTEM

K041575 · Eumedic Limited · GZJ · Jul 16, 2004 · Neurology

Device Facts

• Record ID: K041575
• Device Name: FENZIAN TREATMENT SYSTEM
• Applicant: Eumedic Limited
• Product Code: GZJ · Neurology
• Decision Date: Jul 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS applications: - Symptomatic relief and management of chronic, intractable pain . - Adjunctive treatment for post-surgical and post-trauma acute pain . Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 807 Subpart C)

Device Story

Fenzian Treatment System is a microprocessor-controlled Transcutaneous Electrical Nerve Stimulator (TENS). Device delivers biphasic electrical current through skin to cutaneous and afferent nerves to control pain. System consists of stimulator unit and battery. Operated by healthcare providers or patients for pain management. Device features single alternating output channel, adjustable pulse width (498 µS), frequency (15-350 Hz), and burst mode parameters. Output is delivered via stainless steel electrodes. Device provides symptomatic relief for chronic, intractable pain and adjunctive management for acute post-surgical or post-trauma pain. Clinical benefit derived from nerve stimulation to modulate pain perception.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, risk analysis, and compliance with EN 60601-1-2 standards for electrical safety and electromagnetic compatibility.

Technological Characteristics

Microprocessor-controlled TENS; 9V battery-powered; ABS housing; stainless steel electrodes; biphasic waveform; frequency 15-350 Hz; pulse width 498 µS; single alternating output channel. Complies with EN 60601-1-2 for EMC and safety.

Indications for Use

Indicated for symptomatic relief and management of chronic, intractable pain and as adjunctive treatment for post-surgical and post-trauma acute pain in patients requiring TENS therapy.

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 Focus 795 (K951951)

Submission Summary (Full Text)

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K041575
510k Summary
pg 1 of 7

JUL 1 6 2004

510(k) Summary Fenzian Treatment System

Eumedic Limited 3 Charnham Lane Hungerford, Berkshire RG170EY United Kingdom 44(0)1488684008 Dominic Weiss, Director

Prepared 6-11-04 by: L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 303-530-4774 (fax)

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510 k Summary
p 2 of 7

| Device: | Fenzian Treatment System |
|----------------|--------------------------------------------|
| Common Name: | Transcutaneous Electrical Nerve Stimulator |
| Classification | 882.5890 TENS |
| SE Predicate: | Empi Focus 795<br>K951951<br>882.5890 |

Device Description: The Fenzian Treatment System is an electrical device designed for use as a Transcutaneous Electrical Nerve Stimulator (TENS) which operates by delivering an electrical current through the skin to the cutaneous (surface) and afferent (deep) nerves to control pain. The complete system is comprised of the stimulator and battery.

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## Indications for Use

510(k) Number (if known):

Device Name: Fenzian Treatment System

Indications For Use:

TENS applications:

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

Prescription Use (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 NEDDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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### COMPARISON CHART

:

:

| Feature/Characteristic | Fenzian Treatment System | EMPI - Focus 795, Published Specs |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Unassigned. Application in process. | K951951 |
| Manufacturer | Eumedic Ltd.<br>3 Charnham Lane<br>Hungerford Berkshire RG170EY<br>United Kingdom | Empi, Inc.<br>49 Plain Street<br>North Attleboro, MA 02760<br>U.S.A. |
| Device Classification | Transcutaneous Nerve Stimulator<br>(TENS) 882.5890 | Transcutaneous Nerve Stimulator<br>(TENS) 882.5890 |
| Product Code | 84 GZJ TENS | 84 GZJ TENS |
| Indications | As a TENS device:<br>a) Symptomatic relief and management of chronic, intractable pain<br>b) Adjunctive treatment for post-surgical and post-trauma acute pain | As a TENS device:<br>a) Symptomatic relief and management of chronic, intractable pain<br>b) Adjunctive treatment for post-surgical and post-trauma acute pain |
| Output channels | 1, alternating | 2, simultaneous |
| Regulated voltage | Yes | Yes |
| Indicator display<br>- On/Off display | Yes | Yes |
| - Low Battery | Yes | Yes |
| Weight | 0.4 kg excl. batteries | 145 gm with battery |
| Dimensions | 7 x 2 x 2 inches | 3.7 x 2.5 x 0.84 inches |
| Electrodes | Stainless steel | Snapease Brand |
| Waveform | Biphasic | Symmetrical biphasic |
| Maximum Output Voltages | 88 V @ 500 ohms<br>306 V @ 2 k ohms<br>650 V @ 10 k ohms | $\pm$ 100V @ 1 k ohm |
| Maximum Output Current | 46 milliamps @ 500 ohms<br>16.8 milliamps @ 2 k ohms<br>8.0 milliamps @ 10 k ohms | 0-60 mA (normal)<br>0-100 mA (high) |
| Pulse width | 498 $\mu$ S | 300 $\mu$ S of peak amplitude |
| Frequency | 15-350 Hz | 25, 30, 35, 45, 50, 80 pps |
| Net Charge | 1.16 $\mu$ C@ 500 ohms | 30 $\mu$ C |
| Max. Phase Charge | 10.6 $\mu$ C @ 500 ohms | 40 $\mu$ C @ 500 ohm |
| Feature/Characteristic | Fenzian Treatment System | EMPI - Focus 795, Published<br>Specs |
| Max. Current Density<br>(mA/cm²) | 27.7 mA/cm² @ 500 ohms | 3.11 mA/cm² @ 500 ohms |
| Avg. Power Density<br>(W/cm²) | 0.177 W/cm² @ 500 ohms | 0.187 W/cm² @ 500 ohms |
| Burst Mode | | Unknown |
| - Pulses per burst | 1-8 | |
| - Bursts per second | 15-2800 | |
| - Burst duration | 1-5 seconds | |
| Time On | 1-5 seconds | 2.5 – 50 seconds |
| Off Time | 1 second | 0-50 seconds |
| Power Supply Voltage | 9V | 9V |
| Max. Delivered Current | < 7.0 mA | < 10 mA |
| Range Load of Impedance | 500-1000 ohms | Unknown |
| Controller | Microprocessor | Microprocessor |
| Housing | ABS | ABS |
| Maximum Patient Leakage<br>Current | <100 μΑ | <100 μΑ |
| Maximum Charge per Pulse | 37.5 µC @ 500 ohms | Unknown |
| Maximum Average Current | 2.19 mA | Unknown |

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### Substantial Equivalence Rationale

- 1. The Fenzian Treatment System has the same Indications for Use and equivalent output.
- 2. The technological characteristics are equivalent.
- 3. Comparative information demonstrates substantial equivalence.

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#### Non-Clinical Data:

- 1. Risk Analysis results demonstrate acceptable and mitigated potential hazards.
- 2. The device meets the requirements for EN 60601-1-2 EMC, Radiated Emissions, Electrostatic Discharge, Radiated Immunity and device safety.
- 3. The device meets European requirements for application of the CE Mark.

#### Conclusion:

The device is designed and labeled and verified for performance and safety. The performance is equivalent to a legally marketed predicate device. Risk Analysis does not demonstrate any design or performance potential hazards that are not adequately mitigated.

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Image /page/7/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2004

Eumedic Limited C/o Mr, Lewis W. Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado 80301

Re: K041575

Trade/Device Name: Fenzian Treatment System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: GZJ Dated: June 11, 2004 Received: June 15, 2004

Dear Mr. Ward:

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 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.

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

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Page 2 -- Mr. Lewis W. Ward

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,

Sincerely yours,

Mark A. Milkerner

Celia M. Witten, PhD, MD 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: Fenzian Treatment System

Indications For Use:

TENS applications:

- Symptomatic relief and management of chronic, intractable pain .
- Symptomative for post-surgical and post-trauma 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 NEDDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative,
and Neurological Devices

510(k) Number_ K041575