VITAL STIM

K023347 · Chattanooga Group · IPF · Dec 6, 2002 · Physical Medicine

Device Facts

• Record ID: K023347
• Device Name: VITAL STIM
• Applicant: Chattanooga Group
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Device Story

Chattanooga VitalStim is a powered muscle stimulator designed for pharyngeal muscle re-education. Device applies external electrical stimulation to muscles involved in pharyngeal contraction to assist in rehabilitation. Used in clinical settings by healthcare professionals to treat patients with swallowing difficulties. Output consists of controlled electrical pulses delivered to targeted musculature. Clinical benefit includes improved muscle function and swallowing capability through neuromuscular re-education.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use as a powered muscle stimulator.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850, Product Code IPF). Class II device. Operates via external electrical stimulation for neuromuscular re-education.

Indications for Use

Indicated for patients requiring muscle re-education via external stimulation of muscles involved in pharyngeal contraction.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cheryl L. Bagwell : Regulatory Compliance Specialist Chattanooga Group A Division of Encore Medical 4717 Adams Road P.O. Box 489 Hixson, Tennessee 37343-0489

Re: K023347

Trade/Device Name: Chattanooga VitalStim Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: October 2, 2002 Received: October 7, 2002

Dear Ms. Bagwell:

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

## DFC 0 6 2002

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Page 2 - Chervl L. Bagwell

CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please i 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

l. Mark A. Milhuser

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): | |
|---------------------------|------------------------|
| Device Name: | Chattanooga Vital Stim |

Indications for Use:

- > Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109)

(21 CFR 801.109)

Mark n Millen

(Optional Format 1-2-96)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off) Division of General, Restorative and Neurological Devices

710(k) Number K023347

Attachment I