MBATH 1000 (60)

K052479 · Enneking Medical, Inc. · ILJ · Jan 26, 2006 · Physical Medicine

Device Facts

• Record ID: K052479
• Device Name: MBATH 1000 (60)
• Applicant: Enneking Medical, Inc.
• Product Code: ILJ · Physical Medicine
• Decision Date: Jan 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2

Intended Use

The EMI mBath and eBath is a Product that consists of water agitators and a tub that obtain and hold water. It is used in the bathing of an individual, by an attendant, in either a commercial or residential setting. The eBath uses a microprocessor to control water filling and temperature monitoring, while the mBath uses manual gages. The product is equipped with an integrated AC powered hydraulic lift and transport chair which is available in both 60" and 70" lengths along with an optional door and weight scale.

Device Story

EMI mBath and eBath are immersion hydrobaths for assisted bathing. Systems include tub, water agitators, and integrated AC-powered hydraulic lift/transport chair. eBath utilizes microprocessor for automated water filling and temperature monitoring; mBath utilizes manual gauges. Optional features include door and weight scale. Operated by attendant in residential or commercial settings. Device facilitates hygiene for individuals requiring assistance with bathing; lift mechanism aids patient transfer.

Clinical Evidence

Bench testing only.

Technological Characteristics

Immersion hydrobath; AC-powered hydraulic lift/transport chair; microprocessor control (eBath) or manual gauges (mBath); water agitation system; optional integrated weight scale and door. Product Code: ILJ; Regulation: 21 CFR 890.5100.

Indications for Use

Indicated for the bathing of individuals requiring assistance by an attendant in commercial or residential settings.

Regulatory Classification

Identification

An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 26 2006

Mr. Stephen L. Whittenburg Vice President of Operations Enneking Medical, Inc. 1801 Guinotte Avenue Kansas City, Missouri 64120

Re: K052479

Trade/Device Name: EMI Bath Regulation Number: 21 CFR 890.5100 Regulation Name: Immersion hydrobath Regulatory Class: II Product Code: ILJ Dated: January 6, 2006 Received: January 18, 2006

Dear Mr. Whittenburg:

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 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. Stephen L. Whittenburg

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/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Melkerson

Acting 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): Kø524-79

FATH Device Name: EMI

Indications For Use:

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The eBath uses a microprocessor to control water filling and Selling. The oBath ourg, while the mBath uses manual gages. The temperature monitoring, with an integrated AC powered hydraulic lift anc Froduct is equipped with an integrant can use to assist an individual transport onair in which is available in both 60" and 70" lengths along with an optional door and weight scale.

Prescription Use (Part 21 CFR 801 Subpan D) ANDIOR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line-continue on another pa NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OCE)

Signature

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

Fage 1 of

510(k) Number K052479