EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR

K071624 · Everlife Medical Equipment Co., Ltd. · GZJ · Nov 27, 2007 · Neurology

Device Facts

• Record ID: K071624
• Device Name: EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR
• Applicant: Everlife Medical Equipment Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Nov 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used in symptomatic relief of chronic intractable pain, post-traumatic and post surgical pain

Device Story

Everlife Transcutaneous Nerve Stimulator is a sequenced system for transcutaneous muscle/nerve stimulation. Device consists of a stimulator unit, a sequencer for channel selection, patient cables, and skin-applied electrodes. It outputs various electrical waveforms to generate desired effects on muscles. Patients control signal intensity for safety and comfort. The system may feature multiple output channels for bilateral treatment or simultaneous/serial treatment of multiple body regions. Used in clinical or home settings to provide symptomatic relief of chronic intractable, post-traumatic, and post-surgical pain. Healthcare providers or patients operate the device to manage pain through electrical stimulation.

Clinical Evidence

No clinical data. Bench testing only. Testing included electrical safety, electromagnetic compatibility, and waveform verification to ensure compliance with standards for nerve and muscle stimulators.

Technological Characteristics

Transcutaneous electrical nerve stimulator; multi-channel output; includes stimulator, sequencer, patient cables, and electrodes. Uses shrouded connectors for lead wire safety. Electrical energy source. System-level waveform testing performed. No specific materials or software architecture details provided.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain, post-traumatic pain, and post-surgical pain in patients requiring transcutaneous electrical nerve stimulation.

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

• COM-TENS (K902102)
• COM-TENS (Single Mode) (K931570)
• Apex Medical LCD TENS-VII (K012643)
• TS-1211 (K021755)
• TS-1212 (K021755)
• BIOSCOPE SD TENS (K970429)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS for Transcutaneous Nerve Stimulator

### 510(k) No: K071624

| DATE OF<br>SUBMISSION: | June 1, 2007 | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| SUBMITTER: | EVERLIFE MEDICAL EQUIPMENT CO., LTD.<br>NO 58, FU-CHIUN ST.<br>HSIN-CHU CITY, CHINA (TAIWAN) 30067<br>TEL: [phone]<br>FAX:[phone] | |
| ESTABLISHMENT<br>REGISTRATION NO: | 3004753827 | NOV 27 2007 |
| OFFICIAL<br>CONTACT: | Dr. JEN, KE-MIN<br>NO 58, FU-CHIUN ST.<br>HSIN-CHU CITY, CHINA (TAIWAN) 30067<br>TEL: [phone]<br>FAX:[phone] | |
| TRADE NAME: | EVERLIFE Transcutaneous Nerve Stimulator,<br>T-100201, T-100202, T-100203, T-100801,<br>T-100802, T-100803, T-100501, T100502,<br>SD-100506,T-201110, T-201210, T-201310, T-300708 | |
| COMMON/USUAL<br>NAME: | Transcutaneous Nerve Stimulator | |
| CLASSIFICATION<br>NAME: | Transcutaneous Nerve Stimulator | |
| REGULATION<br>NUMBER: | 882.5890, GZJ, Class II | |
| PREDICATED<br>DEVICE: | APEX Transcutaneous Nerve Stimulator,<br>K902102, K931570, K012643, K021755, K970429,<br>( Please refer to the following comparison page.) | |
| INTENDED USE: | To be used in symptomatic relief of chronic intractable<br>pain, post-traumatic and post surgical pain | |

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# Comparison for Predicate Device & Subject Device

| 510K<br>Number | APEX Model<br>(predicate device) | Everlife Model<br>(new device) | Note |
|----------------|----------------------------------|--------------------------------|-------------------------|
| K902102 | COM-TENS | T-100201 | Identical |
| | | T-100202 | Substantial Equivalence |
| | | T-100501 | Substantial Equivalence |
| | | T-100502 | Substantial Equivalence |
| | | T-100801 | Substantial Equivalence |
| | | T100802 | Substantial Equivalence |
| K931570 | COM-TENS<br>(Single Mode) | T-100203 | Identical |
| | | T-100803 | Substantial Equivalence |
| K012643 | Apex Medical<br>LCD TENS-VII | T-300708 | Identical |
| K021755 | TS-1211 | T-201110 | Identical |
| | TS-1211 | T-201310 | Substantial Equivalence |
| K021755 | TS-1212 | T-201210 | Identical |
| K970429 | BIOSCOPE<br>SD TENS | SD-100506 | Identical |

、

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| Description of Device: | A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Tests Submitted: | The EVERLIFE Transcutaneous Nerve Stimulator has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for safety of nerve and muscle stimulators. Accessories also meet safety requirements: 510(k) electrodes are specified, and the patient cable utilizes shrouded connectors to meet lead wire safety requirements. System level testing including waveform testing was performed in combination the EVERLIFE Transcutaneous Nerve Stimulator. |
| Clinical Tests Submitted: | None |
| Conclusion: | As the product description and tests as above, the new device: EVERLIFE Transcutaneous Nerve Stimulators are as safe and effective as, and the function in a manner equivalent to the predicate devices. Thus the new device is substantially equivalent to the predicate devices in this aspect. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

NOV 2 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Everlife Medical Equipment Co., Ltd. % Dr. Jen Ke-Min No. 58, Fu Chiun Street I Isin Chu City, 30067 Taiwan, ROC

Re: K071624

Trade/Device Name: Everlife Transcutaneous Nerve Stimulator models T-100201, T-100202, T-100501, T-100502, T-100801, T-100802, T-100203, T-100803, T-300708, T-201110, T-201310, T-201210, SD-100506 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: October 29, 2007 Received: November 6, 2007

Dear Dr. Jen Ke-Min:

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 – Dr. Jen Ke-Min

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ought mating of substantial equivalence of your device to a legally prematics notification: "The PDF Interessification 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 11 you active epper for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to [phone]. Fire Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems (Nedical Donoc Reporting (112)); per general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director

Mark N. Melkerson 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: | K071624 |
|----------------|---------|
|----------------|---------|

Device Name:

EVERLIFE Transcutaneous Nerve Stimulator, T-100201, T-100202, T-100203, J T-100801, T-100802, T-100803, T-100501, T100502, SD-100506, T-201110, T-201210, T-201310, T-300708

#### Indications for Use :

To be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

Prescription Use V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

(Division Sign-Off) Division of General, Restorative, and Neurological Device

510(k) Num