SCD GARMENT, MODEL VP530

K061967 · Compression Therapy Concepts, Inc. · JOW · Sep 25, 2006 · Cardiovascular

Device Facts

• Record ID: K061967
• Device Name: SCD GARMENT, MODEL VP530
• Applicant: Compression Therapy Concepts, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Sep 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VasoQuential is designed to increase venous blood flow in at The Vasoquencear in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Device Story

VasoQuential Model VQ530 is a compressible limb sleeve system; functions to increase venous blood flow; primary clinical goal is prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). Device operates via pneumatic compression of limbs; intended for use in clinical or home settings. Healthcare providers or patients utilize the system to provide mechanical prophylaxis against venous stasis. Output is physical compression of the limb; clinical benefit is reduced risk of thromboembolic events.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison to predicate device technology.

Technological Characteristics

Compressible limb sleeve; pneumatic compression mechanism; Class II device; Product Code JOW; Regulation 21 CFR 870.5800.

Indications for Use

Indicated for patients requiring increased venous blood flow to assist in the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2006

Compression Therapy Concepts, Inc. Los Mr. Leonard Nass Vice President 1750 Brielle Ave. Suite B6 Wanamassa, NJ 07712

Re: K061967

Trade Name: VasoQuential, Model VQ530 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: July 11, 2006 Received: July 12, 2006

Dear Mr. Nass:

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.

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## Page 2 - Mr. Leonard Nass

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); 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prediente devise in-aclassifiestion 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Donna R. Vochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K061967

... Device Name ... VasoQuential_model VQ530

Indications For Use:

The VasoQuential is designed to increase venous blood flow in at The Vasoquencear in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

AND / OR Over-The-Counter Use Prescription Use ৯২ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Jackson

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(Division Sign-Off) Division of Cardiovascular Devices

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