FDA.reportPublic FDA data

COMFYEMS

Primary DI
10816924020256
Brand
COMFYEMS
Company
TENSPRODUCTS, INC.
Model
COMFYEMS
Catalog number
COMFYEMS, COMFYEMS-JETT, COMFYEMS-TP, COMFYEMS-MFR
Device description
DIGITAL MUSCLE STIM WITH 3 MODES
Published
2019-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K071951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071951000COMFY SERIES: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd2007-09-05GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816924020389PackageGS11In Commercial Distribution
00816924020747PackageGS11In Commercial Distribution
00816924020792PackageGS11In Commercial Distribution
10816924020256PackageGS132In Commercial Distribution
00816924020259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816924020389008169240203898169240203890816924020389
00816924020747008169240207478169240207470816924020747
00816924020792008169240207928169240207920816924020792
1081692402025610816924020256
00816924020259008169240202598169240202590816924020259

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

Regulatory Flags#

DUNS number
121251883
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
false
Expiration date on label
false
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
10816924020232PRECISION TENS 3900TENS3900V2TENS3900V2, TENS3900-JETT, TENS3900-TP2019-11-21
10816924020249COMFYCOMBPLUSCOMFYCOMBOPLUSCOMFYCOMBOPLUS, COMFYCOMBOPLUS-JETT, COMFYCOMBOPLU2019-11-21
10816924020263COMFYTENSCOMFYTENSCOMFYTENS, COMFYTENS-JETT, COMFYTENS-TP, COMFYTENS2019-11-21
10816924020270PRECISION EMS 6.0EMS6.0EMS6.0, EMS6.0-TP, EMS6.0-MFR2019-11-21
10816924020287TETRATETRATETRA, TETRA-TP2019-11-21
10816924020294TRUTENSTRUTENSV2TRUTENSV22019-11-21
10816924020300PREMIER COMBO PLUSPREMCOMBOPLUSV2PREMCOMBOPLUSV2, PREMCOMBOPLUS-TP2019-11-21
20816924020048TENSPRODUCTS/TENSTRODEKWF125oKWF125o-TP2018-07-12
20816924020062TENSPRODUCTS/TENSTRODEKWF1315KWF1315-TP, KWF1315-MFR2018-07-12
30816924020076TENSPRODUCTS/TENSTRODEKWF2KWF2-TP2018-07-12
30816924020083TENSPRODUCTS/TENSTRODEKWF22KWF22-TP2018-07-12
30816924020120TENSPRODUCTS/TENSTRODEKWF46KWF46-TP, KWF46-MFR, KWF46-JETT2018-07-12
30816924020137TENSPRODUCTS/TENSTRODE4040TC4040TC-TP, 4040TC-MFR, 4040TC-JETT2018-07-12
30816924020151TENSPRODUCTS/TENSTRODEBWT13BWT13-TP, BWT13-MFR2018-07-12
30816924020175TENSPRODUCTS/TENSTRODEKWTS125rKWTS125r-TP2018-07-12
30816924020182TENSPRODUCTS/TENSTRODEKWTS2-TPKWTS2-MFR, KWTS2-JETT2018-07-12
30816924020199TENSPRODUCTS/TENSTRODEKWTS22KWTS22-TPF, KWTS22-JETT2018-07-12
30816924020205TENSPRODUCTS/TENSTRODEKWTS235KWTS235-TP, KWTS235-MFR, KWTS235-JETT2018-07-12
30816924020229TENSPRODUCTS/TENSTRODEKWTS3KWTS3-TP, KWTS3-MFR, KWTS3-JETT2018-07-12
20816924020321TENSPRODUCTS/TENSTRODEKWTS22-TP2018-07-12

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