NORMATEC MVP

K112890 · NormaTec Industries, LP · IRP · Jan 4, 2012 · Physical Medicine

Device Facts

• Record ID: K112890
• Device Name: NORMATEC MVP
• Applicant: NormaTec Industries, LP
• Product Code: IRP · Physical Medicine
• Decision Date: Jan 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NormaTec MVP is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Device Story

NormaTec MVP is a powered inflatable tube massager for home use by healthy individuals. Device consists of an air compressor, manual pressure adjustment bleed-valve, plastic tubing, and inflatable appliances (boot or arm sleeve). Appliance features 5 segments; device delivers cyclically controlled compressed air to simulate kneading and stroking of tissues. User operates device to apply pressure to limbs. Output is mechanical massage; intended to temporarily relieve minor muscle aches/pains and increase local circulation.

Clinical Evidence

Bench testing only. Device underwent safety and quality assurance testing, including compliance with IEC 60601-1 and IEC 60601-1-2 electromagnetic compatibility standards. Results confirmed the device functioned as intended.

Technological Characteristics

Powered inflatable tube massager. Components: air compressor, manual pressure adjustment bleed-valve, 5-segment inflatable appliance (boot/arm sleeve), plastic air tubing, AC/DC adaptor. Principle: cyclic pneumatic compression simulating kneading/stroking. Energy source: AC/DC electrical power. Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for healthy individuals seeking temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas via air pressure massage.

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.

Predicate Devices

• NormaTec PCD (K013436)
• Telebrand Air Press Massager (K032505)
• Pneumatic Peripheral Circulation Improvement Device (PPCID) (K000655)

Submission Summary (Full Text)

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K112890

Pg 1 of 2

JAN - 4 2012

### NormaTec MVP

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Jonathan S. Kahan, Esq. Hogan Lovells 555 Thirteenth Street Washington, DC 20004-1109 Phone: [phone] Facsimile: 202-637-5910

Contact Person: Jonathan S. Kahan

Date Prepared: December 12, 2011

#### Name of Device and Name/Address of Sponsor

NormaTec MVP

Laura F. Jacobs, MD, PhD NormaTec Industries, LP 44 Glen Avenue Newton Center, MA 02459 Phone: [phone] Facsimile: 617-928-3430

Contact Person: Laura F. Jacobs, M.D., Ph.D.

### Common or Usual Name

Powered inflatable tube massager

#### Classification Name

Powered inflatable tube massager IRP 21 C.F.R. § 890.5650

#### Predicate Devices

NormaTec PCD (K013436) Telebrand Air Press Massager (K032505) Pneumatic Peripheral Circulation Improvement Device (PPCID) (K000655)

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#### Intended Use / Indications for Use

The NormaTec MVP is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

#### Technological Characteristics

The NormaTec MVP is a powered inflatable tube massager. It is intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation to the treated areas. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff. The device is to be used by people who are in good health.

The NormaTec MVP consists of an air compressor with a manual pressure adjustment bleed-valve, an inflatable appliance (boot or arm sleeve). plastic air fubing connecting the device to the appliances, and an AC/DC adaptor with power cord. The appliance is divided into 5 segments, with a single tube leading from each segment to the tubing connector on the device.

#### Performance Data

The NormaTec MVP underwent safety testing and quality assurance testing. In all instances, the NormaTec MVP functioned as intended and the results observed were as expected. The NormaTec MVP is in compliance with electromagnetic compatibility standards IEC 60601-1 and IEC 60601-1-2.

#### Substantial Equivalence

The NormaTec MVP is substantially equivalent to its predicates because it has the same intended use, similar indications for use and technological characteristics. The NormaTec MVP and the predicates, the Telebrand Air Press Massager (K032505) and the Pneumatic Peripheral Circulation Improvement Device (PPCID) (K000655), are intended to temporarily relieve minor muscle aches, pains, and to temporarily increase circulation to the treated areas.

NormaTec's MVP has very similar components as its predicate devices and very similar principles of operation. Each device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the inflatable appliance, and control of pressure applied cyclically. Several of the components of the MVP are identical to its predicate, the NormaTec PCD. · The minor technological differences between the MVP and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the MVP is as safe and effective as the predicate device. Thus, the MVP is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the border.

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

JAN - 4 2012

NormaTec Industries, LP % Hogan Lovells US LLP Mr. Jonathan Kahan 555 Thirteenth Street, NW Washington, District of Columbia 20004

Re: K112890

Trade/Device Name: NormaTec MVP Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP, JOW Dated: December 12, 2011 Received: December 12, 2011

Dear Mr. Kahan:

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: GDRH 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

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## Page 2 - Mr. Jonathan Kahan

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 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,
Erin D. Keith

Jor Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number: K112890

Device Name: NormaTec MVP

Indications for Use:

The NormaTec MVP is an air pressure massager intended to temporarily relieve minor muscle The Normal 80 mm - 10 th temporarily increase circulation to the treated areas.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112890