510(k) Report

510(k) · Cleared

Cleared

Thera-Cream, Model TCT004

K032239510(k) TraditionalCleared Jul 30, 2004375-day reviewClass II21 CFR 882.1275

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

Prizm Medical, Inc. · GYB Media, Electroconductive

Cleared on Jul 30, 2004 as substantially equivalent to K024181 (Prizm Medical, Inc., 2003) and 4 other predicates after a 375-day review. Its family tree reaches back 5 generations to 1997. 3 later devices descend from it.

Decided
Jul 30, 2004
Review
375 days
Class
Class II
Product code
GYB
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K961050 (1997). 11 ancestors in all, the oldest K782055 (1979). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1979: 1 other ancestor1999: 2 other ancestors2016: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant clearedK961050 · Reliefband Tens Unit (Modification) · Maven Labs, Inc. · 1997K980333 · Reliefband · Woodside Biomedical, Inc. · 1998K982436 · Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R · Woodside Biomedical, Inc. · 1998K994387 · Reliefband NST Device, Model WB-2L, WB-6L, WB-RL · Woodside Biomedical, Inc. · 2000K020180 · Reliefband Device, Models RB-DL, RB-EL, RB-RL · Woodside Biomedical, Inc. · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants K020180 · Reliefband Device, Models RB-DL, RB-EL, RB-RL · Woodside Biomedical, Inc. · 2002K994387 · Reliefband NST Device, Model WB-2L, WB-6L, WB-RL · Woodside Biomedical, Inc. · 2000K982436 · Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R · Woodside Biomedical, Inc. · 1998K980333 · Reliefband · Woodside Biomedical, Inc. · 1998K961050 · Reliefband Tens Unit (Modification) · Maven Labs, Inc. · 1997−50
  1. Root · 5 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
  2. 4 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
  3. 3 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
  4. 2 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
  5. 1 generation backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
  6. This deviceK032239 Thera-Cream, Model TCT004Prizm Medical, Inc. · 2004
  7. Descendant · cites it directly · 2 of its ownK161654 NuFACE Gel PrimerCarol Cole Company · 2016
  8. Descendant · 2 generations on · 0 of its ownK243749 Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd. · 2025
  9. Descendant · 2 generations on · 0 of its ownK220735 Avologi Gel Primer (Model: Av25)Premier North America, Inc. · 2023

Most influential descendants

Showing 3 of 3 · See all
  • K161654NuFACE Gel PrimerCarol Cole Company · 2016 · cites it directly2descendants
  • K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd. · 2025 · 2 generations on0descendants
  • K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K961050Reliefband Tens Unit (Modification)Maven Labs, Inc.1997—
−4K980333ReliefbandWoodside Biomedical, Inc.1998—
−3K982436Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc.1998—
−2K994387Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc.2000—
−1K020180Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc.2002—
0 (this device)K032239Thera-Cream, Model TCT004Prizm Medical, Inc.2004—
+1K161654NuFACE Gel PrimerCarol Cole Company2016—
+2K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd.2025—
+2K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199310
199510
199920
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202310
202510
FIG. 1 — Lineage of K032239, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Top candidate predicates for a new GYB device

  1. #1 K243749 Jmoon Conductive Gelscore 10.9 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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
*K024181Prizm Medical, Inc. Micro-Z Stimulation System
Summary page 1
…ication Name: Electroconductive Media (21 CFR 882.1275) Product Code: GYB, Neurology Legally Marketed Conduct-MistTM - 510(k) Numbers: K024181 & K951727; Predicate Devices: Conductive Aloe Vera Gel - 510(k) Number: K925466; SignaCrem…
Prizm Medical, Inc.2003—
*K951727Z-Watch System
Summary page 1
…me: Electroconductive Media (21 CFR 882.1275) Product Code: GYB, Neurology Legally Marketed Conduct-MistTM - 510(k) Numbers: K024181 & K951727; Predicate Devices: Conductive Aloe Vera Gel - 510(k) Number: K925466; SignaCreme® - 510(k…
Prizm Medical, Inc.1995—
*K925466Conduct Aloe Gel, #UP239-8FL. OZ/#UP245 G-1 Gallon
Summary page 1
…GYB, Neurology Legally Marketed Conduct-MistTM - 510(k) Numbers: K024181 & K951727; Predicate Devices: Conductive Aloe Vera Gel - 510(k) Number: K925466; SignaCreme® - 510(k) Number: K782055; Ultra/Phonic White - Preamendmen…
Uni-Patch, Inc.1993—
*K782055Cream, Signa
Summary page 1
…(k) Numbers: K024181 & K951727; Predicate Devices: Conductive Aloe Vera Gel - 510(k) Number: K925466; SignaCreme® - 510(k) Number: K782055; Ultra/Phonic White - Preamendment; ReliefBand® Conductivity Gel: 510(k)…
Parker Laboratories, Inc.1979—
*K020180Reliefband Device, Models RB-DL, RB-EL, RB-RL
Summary page 1
…Creme® - 510(k) Number: K782055; Ultra/Phonic White - Preamendment; ReliefBand® Conductivity Gel: 510(k) Number K020180 Device Description: The Prizm Medical Inc.'s Thera-Cream T M product is used prior to electrode placement to reduce the imp…
Woodside Biomedical, Inc.2002—
*—Ultra/Phonic White
Named without a submission number
—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K161654NuFACE Gel PrimerCarol Cole Company20162

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?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
  • None of the 11 ancestors has a recall.
  • Of its descendants, K161654 (Carol Cole Company, 2016) has gone furthest, with 2 descendants of its own.

How does its category compare?

All GYB devices

GYB Media, Electroconductive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GYB

1in 2025

2012: 12016: 12017: 12019: 12020: 32021: 22022: 32023: 12025: 1
2007high 3 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GYB

101in 2022

2020: 198 days median2022: 101 days median
2007high 198 (2020) · low 101 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GYB

1in 2021

2021: 1, 1 Class I
2007high 1 (2021) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GYB

2in 2025

2007: 92008: 42009: 32010: 72011: 102012: 152013: 22014: 52015: 32016: 32017: 42018: 22019: 32020: 22021: 42022: 42023: 62024: 42025: 2
2007high 15 (2012) · low 2 (2013)2025

MAUDE reports naming product code GYB, 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—09
20080—04
20090—03
20100—07
20110—010
20121—015
20130—02
20140—05
20150—03
20161—03
20171—04
20180—02
20191—03
2020319802
20212—1 (1)4
2022310104
20231—06
20240—04
20251—02
20260—0—

What is it indicated for?

Thera-Cream TM is a conductive cream, which increases skin conductivity for electrotherapy treatment and was developed for use with the Prizm brand electrotherapy units and the Intelligent Textiles® brand of garment electrodes.

Indications for use as stated in the FDA summary.

More from Prizm Medical, Inc.

8 FDA decisions under this applicant name. See the company

  • K1335025000Z Firefly SystemPrizm Medical, Inc. · 2014
  • K0331225000Z System (Otc)Prizm Medical, Inc. · 2004
  • K024181Prizm Medical, Inc. Micro-Z Stimulation SystemPrizm Medical, Inc. · 2003
  • K012974Prizm Medical Inc. Thermotrace Infrared Thermometer Models 15004 and 15007Prizm Medical, Inc. · 2002
  • K951727Z-Watch SystemPrizm Medical, Inc. · 1995

Recent decisions in GYB

The GYB category page

  • K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd. · 2025
  • K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc. · 2023
  • K222770Conductive GelTop-Rank Health Care Co., Ltd. · 2022
  • K221724Conductive GelTone-A-Matic International, Inc. · 2022
  • K212325EEG-acpSomnomedics GmbH · 2022

https://510kreport.com/device/K032239 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032239: Thera-Cream, Model TCT004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032239

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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