# K032239: Thera-Cream, Model TCT004

- Pathway: 510(k) (Traditional)
- Applicant: Prizm Medical, Inc.
- Decided: Jul 30, 2004 after 375 days
- Product code: GYB (Media, Electroconductive)
- Device class: 2
- Regulation: 21 CFR 882.1275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961050 (1997). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024181: Prizm Medical, Inc. Micro-Z Stimulation System, Prizm Medical, Inc. (2003) Summary page 1.
- K951727: Z-Watch System, Prizm Medical, Inc. (1995) Summary page 1.
- K925466: Conduct Aloe Gel, #UP239-8FL. OZ/#UP245 G-1 Gallon, Uni-Patch, Inc. (1993) Summary page 1.
- K782055: Cream, Signa, Parker Laboratories, Inc. (1979) Summary page 1.
- K020180: Reliefband Device, Models RB-DL, RB-EL, RB-RL, Woodside Biomedical, Inc. (2002) Summary page 1.
- (no number) Ultra/Phonic White: named in the summary without a submission number

## Most influential descendants
- K161654: NuFACE Gel Primer (2016), 2 descendants of its own
- K243749: Jmoon Conductive Gel (2025), 0 descendants of its own
- K220735: Avologi Gel Primer (Model: Av25) (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K032239
Methodology: https://510kreport.com/methodology