(139 days)
The EMI mBath and eBath is a Product that consists of water agitators and a tub that is used in the bathing of an individual, by an attendee, in either a commercial or residential setting.
The eBath uses a microprocessor to control water filling and emptying, while the mBath uses manual gages. The eBath offers temperature monitoring, with an integrated AC powered hydraulic lift and transport chair in which an attendant can use to assist an individual. The Product is available in both 60" and 70" lengths along with an optional door and weight scale.
This document is a 510(k) clearance letter from the FDA for a medical device called the "EMI Bath." It does not contain any information about acceptance criteria, device performance testing, or studies that prove the device meets acceptance criteria.
The letter primarily states that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices. It lists the trade name, regulation number, regulatory class, and product code, and then outlines the general controls and regulations that the manufacturer must comply with.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a technical report detailing performance studies.
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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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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:
The EMI mBath and eBath is a Product that consists of water The EMP InDath and obtain and obth water. It is used in the bathing agitators and a tub that to mise , in either a commercial or residential of an movidual, by an atteness.
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
§ 890.5100 Immersion hydrobath.
(a)
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.(b)
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.