DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO

K982096 · Rapid Mfg. Co. · GXY · Jun 18, 1999 · Neurology

Device Facts

• Record ID: K982096
• Device Name: DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO
• Applicant: Rapid Mfg. Co.
• Product Code: GXY · Neurology
• Decision Date: Jun 18, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For USE WITH TEN.S and E.M.S DEVICES Only (This Product is not designed as a monitoring electrode and should not be used for that purpose..) Pre-gelled EleCTRODES TO BE UTILIZED WITH TEN'S OR EMS DEVICE

Device Story

Device consists of pre-gelled electrodes designed for use with TENS (Transcutaneous Electrical Nerve Stimulation) or EMS (Electrical Muscle Stimulation) devices. Electrodes interface between stimulation device and patient skin to deliver electrical current. Used in clinical or home settings under prescription or OTC guidance. Electrodes facilitate therapeutic electrical stimulation for pain management or muscle stimulation. Not intended for physiological monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pre-gelled electrodes for TENS/EMS applications. Form factor designed for skin contact to conduct electrical stimulation. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use with TENS or EMS devices for electrical stimulation therapy. Not for use as a monitoring electrode.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 18 1999

Mr. James Willard Lutz CFO Rapid Manufacturing Company 8818 Goodby's Executive Drive Jacksonville, Florida 32217

Re: K982096 Dermastim Plus, Pigtails, Flexstim Trade Name: SuperFlex, Flexstim Plus, Carbonstim, Vertastim, and Enduro Regulatory Class: II Product Code: GXY March 18, 1999 Dated: March 23, 1999 Received:

Dear Mr. Lutz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Raciation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. James Willard Lutz

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

Ph.D., M.D. ia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment I b

Page **_ of _**

510(k) Number (if known):

Device Name: JINS OR EMS Electrodes

Indications For Use:

For USE WITH TEN.S and E.M.S DEVICES Only

(This Product is not designed as a
monitoring electrode and should not be
used for that purpose..)

Pre-gelled EleCTRODES TO BE UTILIZED WITH TEN'S
OR EMS DEVICE

(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 Re 510(k) Nur

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)