MAX-IF1000

K100246 · Bio Protech, Inc. · LIH · Nov 24, 2010 · Neurology

Device Facts

• Record ID: K100246
• Device Name: MAX-IF1000
• Applicant: Bio Protech, Inc.
• Product Code: LIH · Neurology
• Decision Date: Nov 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MAX-IF1000 interferential stimulator is used for symptomatic relief and management of chronic pain and/or an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

Device Story

MAX-IF1000 is an interferential stimulator used for pain management. Device delivers electrical stimulation to patients for symptomatic relief of chronic pain and adjunctive treatment of postsurgical or posttraumatic acute pain. Operated by healthcare professionals or patients in clinical or home settings. Device functions by generating interferential currents to stimulate nerves, aiming to reduce pain perception. Output is delivered via electrodes applied to the skin. Clinical benefit includes non-pharmacological pain management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Interferential electrical stimulator; delivers electrical current via electrodes. Device is unclassified (Product Code: LIH).

Indications for Use

Indicated for symptomatic relief and management of chronic pain, and as adjunctive treatment for postsurgical and posttraumatic acute pain in patients requiring pain management.

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)

{0}------------------------------------------------

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 wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Bio Protech, Inc. c/o Ms. Judy Burton Advena, Ltd 3010 LBJ Frwy. 12th Floor, Dallas, TX 75234

NOV 2 4 2010

Re: K100246

Trade/Device Name: MAX-IF1000 Interferential Stimulator Regulation Number: n/a Regulation Name: n/a Regulatory Class: unclassified Product Code: LIH Dated: November 16, 2010 Received: November 19, 2010

Dear Ms. Burton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic

{1}------------------------------------------------

Page 2 - Ms. Judy Burton

product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Deboral falls

Malvina B. Eydelman, M.D.
Director
Division of Ophthalmic, Neurological,
and Ear, Nose and Throat Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

NOV 2 4 2010

510(k) Number (if known): K100246

MAX-IF1000 Interferential Stimulator Device Name:

Indications For Use:

The MAX-IF1000 interferential stimulator is used for symptomatic relief and management of chronic pain and/or an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aes.

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

X 100246 510(k) Number

Page 1 of 1 1