TRUWAVE

K013210 · Dan Med, Inc. · GZJ · Apr 4, 2002 · Neurology

Device Facts

• Record ID: K013210
• Device Name: TRUWAVE
• Applicant: Dan Med, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Apr 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

TruWave is a transcutaneous electrical nerve stimulator (TENS) used for pain management. The device delivers electrical impulses through electrodes placed on the skin to stimulate nerves for symptomatic relief of chronic intractable, posttraumatic, and post-surgical pain. It is intended for prescription use. The device operates by modulating pain signals via electrical stimulation, which healthcare providers use as a non-pharmacological intervention to assist patients in managing pain symptoms.

Clinical Evidence

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

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS) device; Class II; Product Code GZJ; 21 CFR 882.5890. Operates via electrical stimulation for pain relief.

Indications for Use

Indicated for the management and symptomatic relief of chronic intractable pain, posttraumatic pain, and post-surgical pain in patients requiring such 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 4 2002

Mr. Thomas Sandgaard Dan Med, Inc. 4 West Dry Creek Circle, Suite 260 Denver, CO 80120

Re: K013210

Trade/Device Name: TruWave Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: January 4, 2002 Received: December 28, 2001

Dear Mr. Sandgaard:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered phortes riay 2018) 11:37 accordance with the provisions of the Federal Food, Drug, do noos mat ha v been rout do not require approval of a premarket approval application (PMA). and Cosmetic Hot (110) that to hevice, subject to the general controls provisions of the Act. The r ou may, aterers, mains 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 if your device to such additional controls. Existing major regulations affecting your device can may or subject to back as a sublimations, 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 r 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)

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Page 2 - Mr. Thomas Sandgaard

premarket notification. The FDA finding of substantial equivalence of your device to a legally promance notineation " 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally =1 Cl = Additionally, for questions on the promotion and advertising of your Complanee at (301) 54 ( Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entitutes, which on your responsibilities under the Act may be obtained from the Ourision 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/dsma/dsmamain.html

Sincerely yours,

Mark H. Milken

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

Enclosure

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510(k) Number (if known): K 0/32/ O

Device Name:

TruWave

Indications for Use:

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X .

OR

for Mark n Millere

Sion-() vision of General, Restorative and Neurological Devices

510(k) Number -

Over-The-Counter Use

Optional Format 1-2-96)