FDA.reportPublic FDA data

PRECISION EMS 6.0

Primary DI
00816924020273
Brand
PRECISION EMS 6.0
Company
Tensproducts, LLC
Model
EMS6.0
Catalog number
EMS6.0, EMS6.0-TP, EMS6.0-MFR
Device description
PRECISION EMS 6.0 MUSCLE STIMULATOR
Published
2019-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033544000ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607Everyway Medical Instruments Co.,Ltd2003-12-10IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816924020402PackageGS11In Commercial Distribution
00816924020761PackageGS11In Commercial Distribution
00816924020785PackageGS11In Commercial Distribution
10816924020270PackageGS132In Commercial Distribution
00816924020273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816924020402008169240204028169240204020816924020402
00816924020761008169240207618169240207610816924020761
00816924020785008169240207858169240207850816924020785
1081692402027010816924020270
00816924020273008169240202738169240202730816924020273

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly 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; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Regulatory Flags#

DUNS number
104307787
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816924020235PRECISION TENS 3900TENS3900V2TENS3900V2, TENS3900-JETT, TENS3900-TP2019-11-21
00816924020242COMFYCOMBPLUSCOMFYCOMBOPLUSCOMFYCOMBOPLUS, COMFYCOMBOPLUS-JETT, COMFYCOMBOPLU2019-11-21
00816924020259COMFYEMSCOMFYEMSCOMFYEMS, COMFYEMS-JETT, COMFYEMS-TP, COMFYEMS-MFR2019-11-21
00816924020266COMFYTENSCOMFYTENSCOMFYTENS, COMFYTENS-JETT, COMFYTENS-TP, COMFYTENS2019-11-21
00816924020280TETRATETRATETRA, TETRA-TP2019-11-21
00816924020297TRUTENSTRUTENSV2TRUTENSV22019-11-21
00816924020303PREMIER COMBO PLUSPREMCOMBOPLUSV2PREMCOMBOPLUSV2, PREMCOMBOPLUS-TP2019-11-21
B1900681StemWearPLB054-20302021-09-15
B1900691StemWearPLB054-30500692021-09-15
B1900700StimWearPLB054-30202021-09-15
B1900710StemWearPBL054-30220712021-09-15
B1900720StemWearPLB054-30242021-09-15
B1900730StemWearPLB054-30260732021-09-15
00816924020044TENSPRODUCTS/TENSTRODEKWF125oKWF125o-TP2018-07-12
00816924020068TENSPRODUCTS/TENSTRODEKWF1315KWF1315-TP, KWF1315-MFR2018-07-12
00816924020075TENSPRODUCTS/TENSTRODEKWF2KWF2-TP2018-07-12
00816924020082TENSPRODUCTS/TENSTRODEKWF22KWF22-TP2018-07-12
00816924020129TENSPRODUCTS/TENSTRODEKWF46KWF46-TP, KWF46-MFR, KWF46-JETT2018-07-12
00816924020136TENSPRODUCTS/TENSTRODE4040TC4040TC-TP, 4040TC-MFR, 4040TC-JETT2018-07-12
00816924020150TENSPRODUCTS/TENSTRODEBWT13BWT13-TP, BWT13-MFR2018-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
00816864021682accufitMETTLER ELECTRONICS CORP.IPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
00810188050052L360 Thigh SystemBioness Medical, Inc.IPF2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.IPF2025-07-18
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050144L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050168L100 Go SystemBioness Medical, Inc.IPF2025-07-17