(106 days)
The Reclin-A-Bath 2 is indicated for use with patients to relieve pain and itching. The Reclin-A-Bath 2 is indicated for use with patients to aid in the healing process of inflamed and traumatized tissue. The Reclin-A-Bath 2 is indicated for use with patients to serve as a setting for the removal of contaminated tissue.
Not Found
This document is an FDA 510(k) clearance letter for the Ferno Healthcare Recline-A-Bath 2. It indicates that the device has been deemed substantially equivalent to devices marketed prior to May 28, 1976.
Based on the provided text, there is no information available about acceptance criteria, the study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter focuses on the regulatory clearance process, stating that the device is substantially equivalent and can therefore be marketed. It does not contain the detailed technical or clinical study data that would address the questions posed.
Therefore, I cannot provide the requested table and information based on the input text.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are written around the eagle. The image is in black and white and appears to be a scan or photocopy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 21 1998
Mr. Eric N. Besanko 'Director, Quality Assurance and Regulatory Affairs Ferno-Washington, Inc. 70 Weil Way 45177-9371 Wilmington, Ohio
K980033 Re: Ferno Healthcare Recline-A-Bath 2 Regulatory Class: II Product Code: ILJ Dated: April 2, 1998 Received: April 6, 1998
Dear Mr. Besanko:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
{1}------------------------------------------------
Page 2 - Mr. Eric N. Besanko
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
D. Gale M. Witter, Ph.D., M
ta M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
CONFIDENTIAL
Attachment 1
Indications for use of the Recline-A-Bath 2 Hydrobath
The Reclin-A-Bath 2 is indicated for use with patients to relieve pain and itching.
The Reclin-A-Bath 2 is indicated for use with patients to aid in the healing process of inflamed and traumatized tissue.
The Reclin-A-Bath 2 is indicated for use with patients to serve as a setting for the removal of contaminated tissue. --------------
Over-the-Counter Use
Division Sign Off
Divisio General Restorative Devic 510(k) Number
§ 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.