EMJOI TENS DEVICE

K052711 · Emjoi, Inc. · GZJ · Jun 23, 2006 · Neurology

Device Facts

• Record ID: K052711
• Device Name: EMJOI TENS DEVICE
• Applicant: Emjoi, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Emjoi TENS Device is intended for symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.

Device Story

Emjoi TENS Device provides symptomatic pain relief via transcutaneous electrical nerve stimulation. Device delivers electrical impulses to nerves through skin electrodes; modulates pain signals. Used by patients for chronic intractable, posttraumatic, or post-surgical pain management. Operates as a portable stimulator; user-controlled settings for intensity and frequency. Output affects sensory nerve pathways to provide analgesic benefit. Intended for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use comparison to existing predicate devices.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS). Class II device (21 CFR 882.5890). Operates via electrical stimulation delivered through skin electrodes. Portable form factor. No specific materials, software algorithms, or connectivity features described.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain, posttraumatic pain, and post-surgical 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

PARI Innovative Manufacturers, Inc. % Mr. Mike Judge QA/RA Manager 2943 Oak Lake Boulevard Midlothian, VA 23112

Re: K052711

Trade/Device Name: Emjoi TENS Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: June 19, 2006 Received: June 20, 2006

Dear Mr. Judge:

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. Insting 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. Mike Judge

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/industry/support/index.html.

Sincerely yours,

Hubert Lerner
Mark N. Melkerson

for

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

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## Indications for Use

510(k) Number (if known): N/A

Device Name: Emjoi TENS Device

## Indications for Use:

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The Emjoi TENS Device is intended for symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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(Posted November 13, 2003)

510(k) Number K052711

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