(83 days)
Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
Relaxes muscles, relieves stiffness and muscle spasm.
Stimulates circulation and for other conditions where heat is indicated.
Luxury Paraffin Bath
The provided text is a 510(k) premarket notification letter from the FDA regarding a paraffin bath device. It does not contain any information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested table and details. The document is solely a regulatory approval letter.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2002
Raymond Industrial, Ltd. c/o Mr. Robert T. Wagner President AEGIS, Inc. 972 Weedon Drive, NE St. Petersburg, Florida 33702
Re: K022626
Trade/Device Name: Revlon RVS1212 (MoistureStav) Luxury Paraffin Spa Regulation Number: 21 CFR 890.5110 Regulation Name: Paraffin Bath Regulatory Class: Class II Product Code: IMC Dated: September 1, 2002 Received: October 4, 2002
Dear Mr. Wagner:
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.
{1}------------------------------------------------
Page 2 - Mr. Robert Wagner
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
D. Mark N. Millikan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
STATEMENT OF INDICATIONS FOR USE
Applicant: Helen of Troy
510(K) Number (if known):
Device Name: Luxury Paraffin Bath
Indications For Use:
Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
Relaxes muscles, relieves stiffness and muscle spasm.
Stimulates circulation and for other conditions where heat is indicated.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
L. Mark N. Millman
(Division Sign-Off) Division of General, Restorative and Neurological Dev Page G1
510(k) Number
§ 890.5110 Paraffin bath.
(a)
Identification. A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) and maintained at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.