FDA.reportPublic FDA data

Clinical Health Services, Inc.

Primary DI
00815290017641
Brand
Clinical Health Services, Inc.
Company
CLINICAL HEALTH SERVICES, INC.
Model
TC5050-WF
Catalog number
TC5050-WF
Device description
"TC5050-WF- 2""x2"" electrodes, white foam, carbon, plastic zip lock"
Published
2020-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815290017658PackageGS15In Commercial Distribution
10815290017648PackageGS110In Commercial Distribution
10815290017655PackageGS18In Commercial Distribution
00815290017641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815290017658008152900176588152900176580815290017658
1081529001764810815290017648
1081529001765510815290017655
00815290017641008152900176418152900176410815290017641

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
813-871-3120jeff@clinicalhealthservices.com

Regulatory Flags#

DUNS number
004416769
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815290018310Therapist’s Choice® TENS 2N1TENS 2N1TENS 2N12021-10-28
00815290017719Therapist’s Choice® TENS 7500TENS 7500Digital TENS2021-02-10
00815290013889CLINICAL HEALTH SERVICES, INC.CLIH503X-BLUECLIH503X-BLUE2016-12-09
00815290013896CLINICAL HEALTH SERVICES, INC.CLIC503X-ClearCLIC503X-Clear2016-12-07
00815290013872CLINICAL HEALTH SERVICES, INC.CLID373X-LotionCLID373X-Lotion2016-12-09
00860015112408TENSnet 3MTTENSnet 3MTTENSnet 3MT2025-12-05
10860015112405TENSnet 3MTTENSnet 3MTTENSnet 3MT2025-12-05
00815290017276Therapist’s Choice® TENS 3N1RBTENS 3N1RBTENS 3MT2020-07-06
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseTENS 12MT Small Carrying CaseTENS 12MT2024-12-21
10815290018300Therapist’s Choice® TENS 12MT Small Carrying CaseTENS 12MT Small Carrying CaseTENS 12MT2024-12-21
00815290019409ePower® T1 TENS UNITT1 TENS UNITT1 TENS UNIT2023-09-17
00815290019416ePower® T2 DIGITAL TENST2 DIGITAL TENST2 DIGITAL TENS2023-09-17
00815290019423ePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMS2023-09-17
10815290019406ePower® T1 TENS UNITT1 TENS UNITT1 TENS UNIT2023-09-17
10815290019413ePower® T2 DIGITAL TENST2 DIGITAL TENST2 DIGITAL TENS2023-09-17
10815290019420ePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMS2023-09-17
00815290019232ePower®ePower® E1 EMS UNITePower® E1 EMS UNIT2023-07-15
00815290019249ePower®ePower® E2 DIGITAL EMSePower® E2 DIGITAL EMS2023-07-15
10815290019239ePower®ePower® E1 EMS UNITePower® E1 EMS UNIT2023-07-15
10815290019246ePower®ePower® E2 DIGITAL EMSePower® E2 DIGITAL EMS2023-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973602730894MEDLOTTOP-RANK HEALTH CARE CO., LTD.GXY2026-06-08
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02