JOINT STIM, MODEL 1000

K073386 · Pain Management Technologies · NYN · Jul 30, 2008 · Neurology

Device Facts

• Record ID: K073386
• Device Name: JOINT STIM, MODEL 1000
• Applicant: Pain Management Technologies
• Product Code: NYN · Neurology
• Decision Date: Jul 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The J-Stim 1000 is indicated for use as an adjuctive therapy in reducing the level of pain and symptoms associated with Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand.

Device Story

J-Stim 1000 is a portable, battery-operated, rechargeable transcutaneous electrical nerve stimulator (TENS). Device consists of a signal generator, lead wires, and electrodes. System delivers pulsed electrical signals to treatment sites to reduce pain and symptoms. Operation involves connecting electrodes to the stimulator via lead wires to complete an electrical circuit. Device features an LCD screen for setting adjustments. Used in home or clinical settings under practitioner supervision. Provides non-invasive, non-narcotic electrotherapy for patients with knee osteoarthritis or rheumatoid arthritis of the hand.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and performance characteristics identical to the predicate device.

Technological Characteristics

Portable, battery-operated, rechargeable TENS device. Delivers monophasic spiked pulse electrical signals. Dual-channel output. Voltage range 0-12V peak. Includes LCD screen for user interface. Connectivity is limited to wired electrode connections.

Indications for Use

Indicated for patients requiring adjunctive therapy for pain and symptoms associated with knee osteoarthritis or pain and stiffness associated with rheumatoid arthritis of the hand. Requires prescription and supervision by a licensed practitioner. Suitable for home or clinic use.

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

• The Bionicare Stimulator, Model Bio 1000 - K030332
• K052625

Submission Summary (Full Text)

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Ko73386

# JUL 3 0 2008

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## Pain Management Technologies, Inc. 510(k) submission J-Stim 1000™

### 510(k) Summary of Safety and Effectiveness (As described in 21 CFR 807.92)

| Date Prepared: | 11-1-07 |
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| Trade Name/Device: | J-Stim 1000™ |
| Applicant Information: | Pain Management Technologies, Inc.<br>1340 Home Ave. Bldg. A<br>Akron, OH 44310<br>800-239-7880 (phone)<br>888-304-5454 (fax)<br>Contact: Joshua Lefkovitz<br>Registration No. 1528161 |
| Device Generic Name: | TENS (Transcutaneous Electrical Nerve Stimulator) |
| Classification: | Class II (21CFR 882.1320)<br>Classification Name: Transcutaneous electrical nerve<br>stimulator for pain relief<br>Product Code: NYN<br>Regulation number 21 CFR 882.5890 |
| Predicate Devices: | The Bionicare Stimulator, Model Bio 1000 - K030332<br>and the K052625 |

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| Device Description: | The J-Stim 1000 consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of intended use: | The J-Stim 1000 is indicated for use as an adjuctive therapy in reducing the level of pain and symptoms associated with Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand. |

# Summary of technology of the J-Stim vrs. the predicate Bionicare device:

The J-Stim 1000 and the Bionicare 1000 generate the exact same clectrical output. They produce the same frequency. The same wave form as a monophasic spiked shaped pulse. The same voltage output range which is 0-12 volts peak, as well as the same dual channel output performance. Pulse widths and max output values are identical as well. The J-Stim 1000 utilizes an LCD screen to display the settings

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pain Management Technologies % Mr. Joshua Lefkovitz President 1340 Home Avenue, Building A Akron, Ohio 44310

JUL 30 2008

K073386 Trade/Device Name: J-Stim 1000™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief. Regulatory Class: Class II Product Code: NYN Dated: June 6, 2008 Received: June 13, 2008

Dear Mr. Lefkovitz:

Re:

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

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Page 2 - Mr. Joshua Lefkovitz

forth in the quality systems (OS) 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 marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other 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 M. Mulkerson

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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Pain Management Technologies, Inc. 510(k) submission J-Stim 1000TM

#### Indications for Use Statement

510k Number:K073386

Device Name: J-Stim 1000TM

Indication for Use:

The J-Stim 1000781 external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee.

The J-Stim 1000™ is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.

These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product. The product can be used in the home or clinic by all patients in need.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | √ | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
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Division Sign Off ONE ON ANOTHER PAGE
(IF NEEDED)

Division of General, Restorative,
and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________