IF8000

K991241 · Dan Med, Inc. · IPF · Nov 2, 1999 · Physical Medicine

Device Facts

• Record ID: K991241
• Device Name: IF8000
• Applicant: Dan Med, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

In Interferential Mode: Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain. In NMES Mode: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent deep venous thrombosis. Maintaining or increasing range of motion.

Device Story

The IF8000 is an electrotherapy device providing both Interferential (IF) and Neuromuscular Electrical Stimulation (NMES) modes. It delivers electrical currents to patients to manage pain and support muscle rehabilitation. Operated by healthcare professionals in clinical settings, the device is used for patients suffering from chronic pain or those requiring muscle stimulation post-surgery or post-trauma. The device output is applied via electrodes to the patient's skin. By modulating electrical parameters, the device induces muscle contractions or provides analgesic effects, aiding in the prevention of atrophy, improvement of circulation, and reduction of muscle spasms. Clinical decision-making is guided by the provider's assessment of the patient's pain levels and physical therapy needs.

Clinical Evidence

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

Technological Characteristics

The IF8000 is an electrical stimulator providing Interferential and NMES modalities. It functions as a therapeutic device for pain management and muscle stimulation. Technical details regarding specific materials, dimensions, or software architecture are not provided in the document.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain (Interferential Mode) and for muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent deep venous thrombosis, and maintenance/increase of range of motion (NMES Mode).

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 1999

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

K991241 Re: IF8000 Trade Name: Requlatory Class: II Product Codes: 89 IPF and 84 LIH Dated: July 31, 1999 Received: August 12, 1999

Dear Mr. Sandgaard:

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 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). You may, therefore, market the device, subject to the general controls provisions of The general controls provisions of the Act include the Act. 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 requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Thomas Sandgaard

you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 Also, please note the regulation entitled, at [phone]. "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

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

Enclosure

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K991241 510(k) Number:

IF8000 Device Name:

Indications for use:

In Interferential Mode:

Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.

In NMES Mode:

Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent deep venous thrombosis. Maintaining or increasing range of motion.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use X .

OR

Over-The-Counter Use __

Optional Format 1-2-96)

(Division Sign Division of General Restorat 510(k) Number