EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507

K070890 · Everlife Medical Equipment Co., Ltd. · LIH · Jun 29, 2007 · Neurology

Device Facts

• Record ID: K070890
• Device Name: EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
• Applicant: Everlife Medical Equipment Co., Ltd.
• Product Code: LIH · Neurology
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.

Device Story

Device generates small electrical current pulses; delivered via lead cables to skin-surface electrodes; pulses penetrate skin to activate underlying nerves. Provides symptomatic relief for chronic pain; adjunctive treatment for post-surgical and post-traumatic acute pain. Operated by user/patient; used in home or clinical settings. Output is electrical stimulation; provider/user monitors pain relief levels to adjust therapy. Benefits include non-invasive pain management.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety, electromagnetic compatibility, and waveform testing.

Technological Characteristics

Interferential stimulator; generates electrical pulses. Features lead cables with shrouded connectors for safety. Uses 510(k) cleared electrodes. Tested for electrical safety and electromagnetic compatibility per applicable standards.

Indications for Use

Indicated for symptomatic relief and management of chronic pain and as adjunctive treatment for post-surgical and post-traumatic acute 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

• APEX Interferential Current Therapy, IF-4000 (K952683)

Submission Summary (Full Text)

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Ko70890

## SUMMARY OF SAFETY AND EFFECTIVENESS for Interferential Current Therapy, IF-100507

JUN 2 9 2007

DATE OF SUBMISSION: February 15, 2007 EVERLIFE MEDICAL EQUIPMENT CO., LTD. SUBMITTER: NO 58, FU-CHIUN ST. HSIN-CHU CITY, CHINA (TAIWAN) 30067 TEL: [phone] FAX:[phone]

ESTABLISHMENT

REGISTRATION NO: 3004753827

OFFICIAL CONTACT: Dr. JEN, KE-MIN NO 58, FU-CHIUN ST. HSIN-CHU CITY, CHINA (TAIWAN) 30067 TEL: [phone] FAX:[phone]

TRADE NAME: EVERLIFE Interferential Current Therapy, IF-100507

COMMON/USUAL Interferential Current Therapy

NAME:

Interferential Current Therapy

NAME:

REGULATION NUMBER:

CLASSIFICATION

Pre-Amendment

PREDICATED DEVICE:

APEX Interferential Current Therapy, IF-4000. K952683

- INTENDED USE: The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.
\$\frac{P}{M}\$ 42 1/2

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| Description of<br>Device: | The IF-100507 generates small pulses of electrical<br>current. Delivered along lead cables to electrodes<br>placed on your skin, these pulses pass through the<br>skin and activated underlying nerves. The relief from<br>chronic and acute pain that the IF-100507 can provide<br>results from this electrical stimulation. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Tests<br>Submitted: | The IF-100507 has been tested in accordance with<br>applicable standards for medical device electrical<br>safety, electromagnetic compatibility, and the<br>particular requirements for safety of nerve and muscle<br>stimulators.<br>Accessories also meet safety requirements: 510(k)<br>electrodes are specified, and the patient cable utilizes<br>shrouded connectors to meet lead wire safety<br>requirements.<br>System level testing including waveform testing was<br>performed in combination the IF-100507 stimulator. |
| Clinical Tests<br>Submitted: | None |
| Conclusion: | As the product description and tests as above, the<br>new device: EVERLIFE Interferential Current<br>Therapy, IF-100507 is as safe and effective as, and |

the function in a manner equivalent to the predicate device: APEX Interferential Current Therapy, IF-4000, K952683.

Thus the new device is substantially equivalent to the predicate devices in this aspect.

N ત્રીશ્ 7

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JUN 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Everlife Medical Equipment Co., Ltd. % Ms. Shu-Chen Cheng 2064 Tamarin Drive Columbus. Ohio 43235

Re: K070890

Trade/Device Name: EVERLIFE Interferential Current Therapy, Model IF-100507 Regulatory Class: Unclassified Product Code: LIH Dated: May 23, 2007 Received: May 23, 2007

Dear Ms. Cheng:

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.

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

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Page 2 - Ms. Shu-Chen Cheng

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/industry/support/index.html.

Sincerely yours,

Fur

Mark N. Melkerson
Director
DEP DIASLON
Chalet
Division of General Restorative

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosurc

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## Indications for Use

510(k) Number:

K 070890

Device Name:

EVERLIFE Interferential Current Therapy, IF-100507

Indications for Use :

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.

Prescription Use V (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)

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

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Number

K070890