MASSAGE MATTRESS VM9100RM

K070672 · Metek GmbH · JFB · Jun 26, 2007 · Physical Medicine

Device Facts

• Record ID: K070672
• Device Name: MASSAGE MATTRESS VM9100RM
• Applicant: Metek GmbH
• Product Code: JFB · Physical Medicine
• Decision Date: Jun 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5880
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

To provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the radiant infrared heat provides topical heating for: - > the temporary relief of minor muscle and joint pain and stiffness - > the temporary relief of minor joint pain associated with arthritis - > the temporary increase in local circulation where applied - > muscle relaxation The device is easy and safe to use and can therefore be used in hospitals as well as at home and in gymnasiums. The MASSAGE BED VM9100RM has been produced for over-the-counter use.

Device Story

The Massage Mattress VM9100RM is an electrically powered, motorized physical therapy mattress. It delivers muscle relaxation therapy through two primary modalities: oscillating motors embedded in the mattress body for massage, and heating panels in back and calf pads for radiant infrared heat. The device operates via an indirect, safety low-voltage power circuit. It is intended for use in clinical settings, gymnasiums, or at home by patients for over-the-counter self-administration. Users experience the combined effects of vibration and topical heat, which are intended to alleviate minor pain and stiffness and improve local circulation. The device provides a non-invasive, mechanical and thermal approach to physical therapy.

Clinical Evidence

Bench testing only. The device was tested for electrical safety and performance according to standards EN 60601-1 (1990/1993), EN 50076:1990, EN 60320-1:1996, and BS EN 597-2:1994.

Technological Characteristics

Electrically powered motorized mattress; oscillating motors for vibration; heating panels for radiant infrared heat; safety low-voltage power supply; AC power adapter. Tested to EN 60601-1, EN 50076, EN 60320-1, and BS EN 597-2 standards.

Indications for Use

Indicated for individuals seeking temporary relief of minor muscle/joint pain, stiffness, arthritis-related joint pain, and muscle relaxation, or for increasing local circulation. Suitable for use in hospitals, homes, and gymnasiums; available for over-the-counter use.

Regulatory Classification

Identification

A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.

Predicate Devices

• CERAGEM-C Thermal Massager (K040031)

Submission Summary (Full Text)

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## 10. 510(k) SUMMARY

JUN 26 2007

Pursuant to 513(i)(3)(a) of the Food, Drug and Cosmetic Act, Metek GmbH is required with this pre-market notification to provide either "…adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request by any person. Metek GmbH chose to submit a summary of the safety and effectiveness information. The summary is as follows:

Metek GmbH Submitter's name: Stammweg 8 37327 Leinefelde GERMANY November, 15th, 2006 Date prepared: MASSAGE MATTRESS VM9100RM Proprietary Name: Multi-Function Therapy Table (Class II), Classification Name: 21 CFR 890.5880 CERAGEM-C Thermal Massager (K K040031) Predicate Device Ceragem Company Ltd., Kirkpatrick and Lockhardt LLP, 1800 Massachusetts Avenue, NW Washington, DC 20036 Product description:

The MASSAGE MATTRESS VM9100RM is an electrically powered motorized multi-functional physical therapy mattress. It is intended to provide muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by oscillating motors that are embedded in the mattress body. The heat function is delivered by two components (1) a back pad and (2) a calf pad both containing a heating panel. In both cases, radiant infrared heat is emitted. Both, the oscillating function and the heated pressure apply light pressure as well as radiate infrared heat to the user.

Discussion of Technological Characteristics:

Both, the MASSAGE MATTRESS VM9100RM and the predicate device provide massage and heat to muscle relaxation therapy. The MASSAGE MATTRESS VM9100RM does not use jade rollers to provide the massage function as the predicate operates with. Instead it uses oscillating motors to deliver vibrations to

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the user. The predicate devices also emits heat through EPOXY CARBON PANELS, whereas the MASSAGE MATTRESS VM9100RM uses only two panels, located in two pads. While the predicate device uses direct power supply, the MASSAGE MATTRESS VM9100RM uses indirect, safety low-voltage power. It is supplied by a power circuit.

Standards tested

The standards tested are

- -EN 60601-1: 1990 A1
- EN 60601-1: 1990 A2 ।

In case there is a need to use another power circuit supplied, this was tested according to the standards

- EN 60601-1:1990 -
- -EN 60601-1:1993 A1
- EN 60601-1:1993 A2 -

The AC power adapter used was tested according to the standards

- i EN 50076:1990 and
- -EN 60320-1: 1996 + A1 + A2

The Certificates No. 60009868, 2156443, and the Test Report No. 21123617_001 are attached to the 510(k).

The product as a complete product was tested according to the standard BS EN 597-2: 1994 a

The Test Report No.21129516001 are attached to the 510(k).

The device is intended:

To provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the radiant infrared heat provides topical heating for:

- > the temporary relief of minor muscle and joint pain and stiffness
- > the temporary relief of minor joint pain associated with arthritis
- > the temporary increase in local circulation where applied
- > muscle relaxation

The device is easy and safe to use and can therefore be used in hospitals as well as at home and in gymnasiums. There is no recommendation or restriction on how often the device should be used in order to treat the symptoms described.

The MASSAGE BED VM9100RM has been produced for over-the-counter use.

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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 is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with three curved lines representing its wings and a wavy line representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Metek GmbH % Tamas Borsai TÜV Rheinland 12 Commerce Road Newton, Connecticut 06470

JUN 2 6 2007

Re: K070672

Trade Name: Massage Mattress VM9100RM Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function Physical Therapy Table Regulatory Class: Class II Product Code: JFB Dated: June 13, 2007 Received: June 15, 2007

Dear Mr. Borsai:

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. Iisting 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 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.

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Page 2 - Mr. Tamas Borsai

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Foh Pedro hma

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## 1. INDICATION FOR USE

## Device name: MASSAGE MATT.RESS VM9100RM

The device is intended:

To provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the radiant infrared heat provides topical heating for:

- > the temporary relief of minor muscle and joint pain and stiffness
- > the temporary relief of minor joint pain associated with arthritis
- > the temporary increase in local circulation where applied
- > muscle relaxation

The device is easy and safe to use and can therefore be used in hospitals as well as at home and in gymnasjums.

The MASSAGE BED VM9100R as been produced for over-the-counter use.

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

**510(k) Number** L640672

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

Concurrence of CDRH, Office of Device evaluation

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