ATLANT'S

K974395 · Grad-Line Corp. · IRP · Oct 22, 1998 · Physical Medicine

Device Facts

• Record ID: K974395
• Device Name: ATLANT'S
• Applicant: Grad-Line Corp.
• Product Code: IRP · Physical Medicine
• Decision Date: Oct 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the treatment of chronic venous insufficiency, lymphedema, edema of venous origin, post amputation, lymphatic obstruction and contusions.

Device Story

ATLANT'S is a medical device intended for the treatment of chronic venous insufficiency, lymphedema, edema of venous origin, post-amputation conditions, lymphatic obstruction, and contusions. The device is used in a clinical setting under prescription. It functions to provide therapeutic compression or physical support to manage fluid accumulation and venous/lymphatic conditions. The healthcare provider utilizes the device to alleviate symptoms associated with the listed conditions, potentially improving patient comfort and reducing edema.

Indications for Use

Indicated for patients requiring treatment for chronic venous insufficiency, lymphedema, edema of venous origin, post-amputation conditions, lymphatic obstruction, and contusions.

Regulatory Classification

Identification

A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

OCT 22 1998

Mr. Walter L. Wasserman
Agent for Grad-Line Corporation
762 South Federal Highway
Deerfield Beach, Florida 33441

Re: K974395
Trade Name: ATLANT'S
Regulatory Class: II
Product Code: IRP
Dated: July 28, 1998
Received: July 31, 1998

Dear Mr. Wasserman:

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 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 (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 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 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.

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Page 2 - Mr. Walter L. Wasserman

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

Enclosure

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GRAD-LINE (CONFIDENTIAL)

510 (k) Number – K974395
Device Name – ATLANT'S

Indications For Use:

For the treatment of chronic venous insufficiency, lymphedema, edema of venous origin, post amputation, lymphatic obstruction and contusions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)


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THE MATERIALS CONTAINED WITHIN THIS SUBMISSION MARKED AS CONFIDENTIAL MAY NOT BE DISTRIBUTED OUTSIDE THE US GOVERNMENT WITHOUT THE WRITTEN CONSENT OF GRAD-LINE