FDA.reportPublic FDA data

Thera-Cream

Primary DI
B872TCT0041
Brand
Thera-Cream
Company
PRIZM MEDICAL, INC.
Model
TCT004
Published
2020-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
GYBMedia, Electroconductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032239000THERA-CREAM, MODEL TCT004Prizm Medical, Inc.2004-07-30GYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B872TCT0041PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
790271118
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B872MZ2KIT20Micro-Z IIMZ2KIT22020-05-12
B872MZM1000Micro-Z Mini MZM1002020-05-07
B872MZS2KIT20Micro-Z IIMZ2KIT22020-05-07
B872ITBK440Intelligent Textile Stim-Support Back WrapITBK442024-06-07
B872SSELBW0Stim-Support Elbow BraceSSELBW2024-06-07
B872SSKNEE0Stim-Support Knee BraceSSKNEE2024-06-07
B872SSNECK0Stim-Support Neck BraceSSNECK2024-06-07
B872SSSHLD0Stim-Support Shoulder BraceSSSHLD2024-06-07
B872EMG20130Electro-Mesh GloveEMG20132024-06-06
B872EMSP240Electro-Mesh PanelEMSP242024-06-06
B872EMSP440Electro-Mesh PanelEMSP442024-06-06
B872EMSP480Electro-Mesh PanelEMSP482024-06-06
B872STS33130Silver-Thera SockSTS33132024-06-06
B872STS33140Silver-Thera SockSTS33142024-06-06
B872STS33150Silver-Thera SockSTS33152024-06-06
B872SSS23050Stim-Support Shoulder - XLSSS 23052020-05-11
B872SPZ2000Sport-ZSPZ2002020-05-11
B872REVSTM20ReviStimREVSTM22020-05-07
D20007Micro-Z IIMZ2KIT22020-05-12
B872EMG20140Electro-Mesh GloveEMG20142020-05-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09342451003430Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003447Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
00197998355363Solventum™Solventum US LLCGYB2026-02-15
00197998355400Solventum™Solventum US LLCGYB2026-02-15
00197998355370Solventum™Solventum US LLCGYB2026-02-15
00197998355417Solventum™Solventum US LLCGYB2026-02-15
06973602730795FyneLookTOP-RANK HEALTH CARE CO., LTD.GYB2025-10-23
06974667824986JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
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16974667824990JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
16974667825003JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
06973602730627MedvatTOP-RANK HEALTH CARE CO., LTD.GYB2025-04-23
06973602730610MedvatTOP-RANK HEALTH CARE CO., LTD.GYB2025-03-18
00850024089235MedvatMyt Enterprises LLCGYB2025-02-19
00840295408224TherabodyTherabody, Inc.GYB2025-01-26
B1870800TheraMistNEUROTRON MEDICAL, INC.GYB2024-12-04
06971292004011AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-29
16971292006739AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
16971292006746AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
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26971292006743AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
04260280180335AxionAxion USA LLCGYB2024-03-18
04262356159993EEG-acpCNSAC Medshop GmbHGYB2024-01-22
B311PEHTNPDS20PURE ENRICHMENTBEAR DOWN CONSULTINGGYB2023-12-14
B311PEHTNPDS50PURE ENRICHMENTBEAR DOWN CONSULTINGGYB2023-12-14
00850021097561Nu Skin RenuSpa iO PackageNSE PRODUCTS, INC.GYB2023-11-27