(59 days)
Not Found
No
The device description details a simple heated paraffin wax spa with electronic temperature and timing controls, with no mention of AI or ML capabilities.
Yes
The intended use explicitly states symptomatic relief of pain, muscle relaxation, and stimulation of circulation for medical conditions, which are therapeutic claims.
No
Explanation: The device is a heated paraffin wax spa for symptomatic relief of pain, muscle relaxation, and circulation stimulation, not for diagnosing conditions.
No
The device description clearly states it is a heated paraffin wax spa consisting of a plastic enclosure, aluminum bucket, and internal heating assembly, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The description clearly states this is a heated paraffin wax spa intended for home use to provide symptomatic relief of pain and relax muscles. It applies heat externally to the body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
- Lack of IVD-related terms: The document does not contain any terms or descriptions related to laboratory testing, specimen collection, or diagnostic analysis.
Therefore, this device falls under the category of a therapeutic device that applies heat externally, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- Useful for symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
- Relaxes muscles, relieves stiffness and muscle spasm. 2.
-
- Stimulates circulation and for other conditions where heat is indicated.
Product codes
IMC
Device Description
The product covered by this 510(k) summary is a heated paraffin wax spa intended for home use. This product consists of a plastic enclosure, aluminum bucket and an internal heating assembly. The paraffin wax temperature is controlled by a variable electronic heat control with timing circuit. Temperature settings (low, medium, and high) and timing controls are displayed on a liquid crystal display. The product consumes 200 watts when plugged into a standard household electrical outlet supply of 120 Vac, 60 Hertz. The product comes in two different sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEC 0 3 2001
REMINGTON REMINGTON PRODUC OMPANY L.L.C.
| Preparation Date: | October 5, 2001 |
|---|---|
| Contact Person: | Tim Simmone |
| Senior Vice President and Chief Technical Officer | |
| Remington Products Company, L.L.C. | |
| 60 Main Street | |
| Bridgeport, Connecticut 06604 | |
| (T) (203) 367-4400 | |
| (F) (203) 332-4607 | |
| Proprietary Name: | Remington® Paraffin Spa (Models HS-250 and PFS-600) |
| Common/Usual Name: | Paraffin Bath |
| Classification Name: | Paraffin Bath (per 21 C.F.R. § 890.5110) |
Classification: Class II
Description:
The product covered by this 510(k) summary is a heated paraffin wax spa intended for home use. This product consists of a plastic enclosure, aluminum bucket and an internal heating assembly. The paraffin wax temperature is controlled by a variable electronic heat control with timing circuit. Temperature settings (low, medium, and high) and timing controls are displayed on a liquid crystal display. The product consumes 200 watts when plugged into a standard household electrical outlet supply of 120 Vac, 60 Hertz. The product comes in two different sizes.
Intended Use:
-
- Useful for symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
- Relaxes muscles, relieves stiffness and muscle spasm. 2.
-
- Stimulates circulation and for other conditions where heat is indicated.
Substantial Equivalence Claim:
The Remington Paraffin Spa® is substantially equivalent to the following legally marketed predicate device: ParaSpaTM Paraffin Bath by Homedics, Inc. (K001860).
Substantial equivalence is claimed because the Remington Paraffin Spa® and the HoMedics ParaSpa™ Paraffin Bath have the same intended use and very similar principles of operation and technological characteristics. Moreover, none of the minor technological differences between the two products raises any new questions of safety or effectiveness.
6-1
Tim Simmone Vice President and Chief Technical Officer
1
Image /page/1/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 top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
DEC 0 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Remington Products Company, L.L.C. c/o Ms. Pamela J. Furman Olsson, Frank and Weeda, P.C. 1400 Sixteenth Street, NW Suite 400 Washington, D.C. 20036-2220
Re: K013328
Trade/Device Name: Remington® Paraffin Spa (Models HS-250) and PFS-600) Regulation Number: 890.5110 Regulation Name: Paraffin Bath Regulatory Class: Class II Product Code: IMC Dated: October 5, 2001 Received: October 5, 2001
Dear Ms. Furman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) presidentially equivalent (for the indications felerenced above and nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally many of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device American Dev commerce print to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have occh recussion in quire approval of a premarket approval application (PMA). and Cosmetic rear (1101) that ao november to the general controls provisions of the Act. The Tou may, dicrorore, mainer of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classinod (600 a00 ro) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou that I Drains on that your device complies with other requirements of the Act that I Drivias Intatutes and regulations administered by other Federal agencies. You must or any I cathates and the Act's requirements, including, but not limited to: registration and listing
2
Page 2 - Ms. Pamela J. Furman
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,
Mark N. Milliberson
Celia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Collia U.S. Food and Drug Administration = Center for Devices and Radiological Health = 1
(Not yet assigned) 510(k) Number (if known):
Remington® Paraffin Spa Device Name:
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. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
《中東京都書館 歌曲歌歌曲 (三) 出版 (代表
rence of CDRH, Office of Device Evaluation (ODE)
3-1
(Optional Format 3-10-98)
Restorative
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