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510(k) K032239

THERA-CREAM, MODEL TCT004 by Prizm Medical, Inc. — Product Code GYB

K032239 is an FDA 510(k) premarket notification submitted by Prizm Medical, Inc. for the device "THERA-CREAM, MODEL TCT004". The FDA issued a decision of Substantially Equivalent on July 30, 2004. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Prizm Medical, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2004
Date Received
July 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Prizm Medical, Inc.

  • K133502 — 5000Z FIREFLY SYSTEM (December 3, 2014)
  • K033122 — 5000Z SYSTEM (OTC) (August 25, 2004)
  • K024181 — PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM (June 26, 2003)
  • K012974 — PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 (July 23, 2002)
  • K951727 — Z-WATCH SYSTEM (November 21, 1995)
  • K944487 — ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES (February 21, 1995)
  • K932299 — ELECTRO-MESH (July 1, 1994)

Other clearances for product code GYB

  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K220735 — Avologi Gel Primer (Model: Av25) (September 15, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K221724 — Conductive Gel (September 23, 2022)
  • K212325 — EEG-acp (June 15, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K192606 — SAC2 - Electrode Cream (January 17, 2020)

FDA data resources