FDA.reportPublic FDA data

TensRx Body Select

Primary DI
80092237620447
Brand
TensRx Body Select
Company
Compass Richmar, LLC
Model
DI1077-TRX
Device description
Private labeled InTENSity 10 unit for TensRx.
Published
2018-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80092237620447PackageGS132In Commercial Distribution
00092237620441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223762044780092237620447
00092237620441000922376204410922376204410092237620441

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
080930531
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
80092237621055Richmar TheraTouch DQLLLT2019-02-08
80092237621475Richmar TheraTouchDQ72002019-02-08
80092237620454TensRx Dual ComboDI3777-TRX2018-08-23
80092237900433Equipos Private Labeled SuperStim 3" Round400-888-EQUIPOS2018-09-27
80092237900884UltraStick - HJ & Associates PL203-8142019-01-18
80092237900891UltraStick - HJ & Associates PL 203-8152019-01-18
80092237900907UltraStick - HJ & Associates PL 203-8162019-01-18
30092237900919UltraStick - HJ & Asssociates PL 203-8172019-01-18
80092237900921UltraStick - HJ & Associates PL 203-8182019-01-18
80092237900938UltraStick - HJ & Associates PL 203-8192019-01-18
80092237900945UltraStick - HJ & Associates PL 203-8322019-01-18
80092237900952UltraStick - HJ & Associates PL 203-8332019-01-18
80092237902246MicroBlock Antimicrobial Electrode400-872-MIC2019-01-08
80092237900440Medical Science Private Label203-4932019-01-07
80092237900457Medidcal Science Products Private Label203-4832019-01-07
80092237900464Medical Science Products Private Label203-4822019-01-07
80092237900471Medical Science Products Private Label203-4842019-01-07
80092237901027ValueStim202-6752019-01-07
80092237901034ValueStim202-6762019-01-07
80092237900532ScripHessco 2"672 01922018-09-27

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