FDA.reportPublic FDA data

Protekt Titanium Deluxe Dual Channel TENS

Primary DI
05060488570940
Brand
Protekt Titanium Deluxe Dual Channel TENS
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
PMTENSDDC
Catalog number
PMTENSDDC
Device description
Protekt Titanium Deluxe Dual Channel TENS
Published
2020-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003487000STIMATE N601 TENSEveryway Medical Instruments Co.,Ltd2001-01-24GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488570940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488570940050604885709405060488570940

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4Inch
Length10Inch
Width12Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 855 237 7622sales@proactivemedical.com

Regulatory Flags#

DUNS number
078582655
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05061105057455Protekt VX 5000PMVSM5000PMVSM50002025-12-18
05060488573293Protekt PartsPP-AHDAASMK3LFTPP-AHDAASMK3LFT2022-11-18
05060488573309Protekt PartsPP-AHDAASMK3RTPP-AHDAASMK3RT2022-11-18
05060488573316Protekt PartsPP-AHFAASMK3LFTPP-AHFAASMK3LFT2022-11-18
05060488573323Protekt PartsPP-AHFAASMK3RTPP-AHFAASMK3RT2022-11-18
05060488572401Protekt LiftPL400HPL400H2022-05-11
05060488570902Procure Nebulizer002-102785002-1027852020-01-01
05060488570926Procure Blood Pressure Monitor, Digital, Auto Inflate w/ Batteries002-102738002-1027382020-01-01
05060488570162Protekt Aire94001940012016-08-12
05060488570179Protekt Aire94003940032016-08-12
05060488570186Protekt Aire94004940042016-08-12
05060488570452Protekt Aire Replacement Pump80091800912016-08-12
05060488570490Protekt Aire Replacement Mattress80032800322016-08-12
05060488570506Protekt Aire Replacement Mattress80042800422016-08-12
05060488570544Protekt Aire Replacement Mattress80082800822016-08-12
05060488570551Protekt Aire Replacement Mattress80087800872016-08-12
05060488570728Protekt Aire83500835002018-03-07
05060488570735Protekt Aire83600836002018-03-07
05060488570742Protekt Aire84600846002018-03-07
05060488570773Protekt Aire81090-42B81090-42B2018-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
00810140062680RENPHOJoicom CorporationGZJ2025-10-20
00810140062697RENPHOJoicom CorporationGZJ2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.GZJ2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.GZJ2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.GZJ2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.GZJ2025-09-11
00810113683379DualPulse CompactManamed, Inc.GZJ2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.GZJ2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.GZJ2025-08-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
00661168000037Reliefband® Sport - BlackRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000044Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000167Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000181Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseCLINICAL HEALTH SERVICES, INC.GZJ2024-12-21
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00810113683218ManaMedManamed, Inc.GZJ2024-04-30
B786SBM1AB0110actiTENSSUBLIMEDGZJ2024-04-24
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
B731P12T109TrueReliefTruerelief, LLCGZJ2024-01-08
00815290019409ePower® T1 TENS UNITCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17