510(k) Report

510(k) · Cleared

Cleared

Revlon RVSP3501 Spa Moisturestay Paraffin Bath (Type SPB3752EA)

K093100510(k) TraditionalCleared Nov 24, 200954-day reviewClass II21 CFR 890.5110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Shenzhen Comfort Technology Co., Ltd. · IMC Bath, Paraffin

Cleared on Nov 24, 2009 as substantially equivalent to K022626 (Raymond Industrial, Ltd., 2002) after a 54-day review. Its family tree reaches back 1 generation to 2002.

Decided
Nov 24, 2009
Review
54 days
Class
Class II
Product code
IMC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K022626 (2002). No later device cites it as a predicate yet.

K022626 · Moisturestay (Revlon) · Raymond Industrial, Ltd. · 2002200020022004200620082010
K022626 · Moisturestay (Revlon) · Raymond Industrial, Ltd. · 20020
  1. Root · 1 generation backK022626 Moisturestay (Revlon)Raymond Industrial, Ltd. · 2002
  2. This deviceK093100 Revlon RVSP3501 Spa Moisturestay Paraffin Bath (Type SPB3752EA)Shenzhen Comfort Technology Co., Ltd. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K022626Moisturestay (Revlon)Raymond Industrial, Ltd.2002—
0 (this device)K093100Revlon RVSP3501 Spa Moisturestay Paraffin Bath (Type SPB3752EA)Shenzhen Comfort Technology Co., Ltd.2009—
FIG. 1 — Lineage of K093100, 2002–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IMC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K022626Moisturestay (Revlon)
Summary page 2
…nce 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…
Raymond Industrial, Ltd.2002—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All IMC devices

IMC Bath, Paraffin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · IMC

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IMC

Too few IMC 510(k)s in any year since 2007 to give a median.

Recalls per year · IMC

No recall names IMC since 2007.

Adverse event reports per year · IMC

4in 2025

2007: 72008: 22009: 32010: 22011: 22014: 22017: 12018: 32019: 22020: 12021: 12022: 52024: 32025: 4
2007high 7 (2007) · low 0 (2012)2025

MAUDE reports naming product code IMC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—07
20080—02
20091—03
20100—02
20110—02
20120—00
20130—00
20140—02
20150—00
20160—00
20170—01
20180—03
20190—02
20200—01
20210—01
20220—05
20230—00
20240—03
20250—04
20260—0—

What is it indicated for?

The Revlon RVSP3501 (Type SPB3752EA) 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.

Indications for use as stated in the FDA summary.

Recent decisions in IMC

The IMC category page

  • K022626Moisturestay (Revlon)Raymond Industrial, Ltd. · 2002
  • K013707Softique, Model GI 11001Global TV Concepts, Ltd. · 2002
  • K013328Remington Paraffin Spa, Models HS-200. PFS-600Remington Products Company, LLC · 2001
  • K001860Paraspa Paraffin Bath, Paraspap Mini, Paraspa UltraHomedics, Inc. · 2000
  • K991427Paramed Paraffin WarmerDivi Intl. Co. · 1999

https://510kreport.com/device/K093100 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093100: Revlon RVSP3501 Spa Moisturestay Paraffin Bath (Type SPB3752EA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093100

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026