(54 days)
Not Found
No
The device description and intended use are for a simple paraffin bath with a thermostat, and there is no mention of AI or ML in the document.
Yes
The device is intended for "symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation," and "relaxes muscles, relieves stiffness and muscle spasm," which are therapeutic claims.
No
A diagnostic device is used to detect, diagnose, or monitor a disease or condition. This device is described as providing symptomatic relief, muscle relaxation, stiffness relief, and stimulating circulation, which are all therapeutic or comfort-oriented uses, not diagnostic ones.
No
The device description clearly outlines a physical hardware unit (paraffin bath) with electrical components (heater, thermostat, LEDs) and accessories (wax, mat, liners, mitts). It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Revlon RVSP3501 Spa MoistureStay Paraffin Bath is a physical therapy device that applies heat to the body using melted paraffin wax. It is used for symptomatic relief of pain and stiffness.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is purely external and therapeutic.
The information provided clearly describes a device used for external heat therapy, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is: - Useful in symptomatic relief of pain caused by arthritis, and chronic joint inflammation. . - Relaxes muscles, relieves stiffness and muscle spasm . - Stimulates circulation and for other conditions where heat is indicated.
Product codes (comma separated list FDA assigned to the subject device)
IMC
Device Description
The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is an 80 Watt paraffin bath unit, with a thermostat that varies the heat from High to Keep Warm. There are two LEDs, a red LED for the heater, and a green LED to indicate the power. The unit is provided with 3lbs of paraffin wax, a plastic mat when dipping the hands or feet, glove liners, and a pair of mitts.
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
Not Found
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)
The Revlon RVSP3501 Spa MoistureStay Paraffin Bath was evaluated and found to comply with the applicable requirements of the following standards: - UL1431 Standard for Personal Hygiene and Health Care Appliances, 2nd Edition, 0 November 22, 1996, revised March 26, 2007 - o Canadian Standard for Household Cooking and Liquid-Heating Appliances, CAN/CSA C22.2 No. 64-M91 (R2003) . Performance Testing The Revlon RVSP3501 Spa MoistureStay Paraffin Bath - Type SPB3752EA was tested alongside the Revlon Model RVS1212 Luxury Paraffin Spa (K022626). The major difference between the two units was the time required to melt the wax, as was expected, because of the significant difference in power consumption
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary (per 21 CFR 807.92(c))
1. Applicant
Shenzhen Comfort Technology Co. Ltd. No. 3 Building North Nanling Road Xiner Industrial Zone Shenzhen, China
NOV 2 4 2009
Mr. Jack Zhou, General Manager Tel: 86 755 2741 5168 Fax: 86 755 2741 5579 E-mail: jack@easepal.com.cn
Date Prepared: August 5, 2009
-
- Device Name
| Device Name: | Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath |
|---|---|
| Regulation Description: | Paraffin bath |
| Regulation Number: | 890.5110 |
| Product Code: | IMC |
| Device Class: | II |
| Review Panel: | Physical Medicine |
3. Predicate Devices
The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is substantially equivalent to the following device:
| 510(k) Number | Device | Applicant |
|---|---|---|
| K022626 | Revlon RVS1212 (MoistureStay) Luxury | |
| Paraffin Spa | Raymond Industrial, Ltd. |
4. Indications for Use
The Revlon RVSP3501 Spa MoistureStay Paraffin Bath is:
- . 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.
1
5. Description of the Device
The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is an 80 Watt paraffin bath unit, with a thermostat that varies the heat from High to Keep Warm. There are two LEDs, a red LED for the heater, and a green LED to indicate the power. The unit is provided with 3lbs of paraffin wax, a plastic mat when dipping the hands or feet, glove liners, and a pair of mitts.
6. Summary of the Technical Characteristics
-
. Safety Testing
The Revlon RVSP3501 Spa MoistureStay Paraffin Bath was evaluated and found to comply with the applicable requirements of the following standards: -
UL1431 Standard for Personal Hygiene and Health Care Appliances, 2nd Edition, 0 November 22, 1996, revised March 26, 2007
-
o Canadian Standard for Household Cooking and Liquid-Heating Appliances, CAN/CSA C22.2 No. 64-M91 (R2003)
-
. Performance Testing
The Revlon RVSP3501 Spa MoistureStay Paraffin Bath - Type SPB3752EA was tested alongside the Revlon Model RVS1212 Luxury Paraffin Spa (K022626). The major difference between the two units was the time required to melt the wax, as was expected, because of the significant difference in power consumption
7. Safety and Effectiveness
The Revlon RVSP3501 Spa MoistureStay Paraffin Bath has been shown to be as safe and as effective as the predicate device listed in this 510(k) submission; that is, both the Revlon RVSP3501 Spa MoistureStay Paraffin Bath and the Revion RVS1212 (MoistureStay) Luxury Paraffin Spa have the same indications for use and are similar in both design and function. Any differences in technological characteristics between the Revlon RVSP3501 Spa MoistureStay Paraffin Bath and the predicate device do not raise issues of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle or bird with outstretched wings. The bird's body is formed by three curved lines, giving it a modern and abstract appearance.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 2 4 2009
Shenzhen Comfort Technology Co., Ltd. % Intertek Testing Services NA, Inc. Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K093100
Trade/Device Name: Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath
Regulation Number: 21 CFR 890.5110 Regulation Name: Paraffin bath. Regulatory Class: Class II Product Code: IMC Dated: November 9, 2009 Received: November 10, 2009
Dear Mr. Lehtonen:
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 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.
3
Page 2- Mr. Daniel W. Lehtonen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _
Device Name: Revion RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath
Indications for Use:
The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is:
- Useful in symptomatic relief of pain caused by arthritis, and chronic joint inflammation. .
- Relaxes muscles, relieves stiffness and muscle spasm .
- Stimulates circulation and for other conditions where heat is indicated.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
bpart C)
X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M. MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093100