FDA.reportPublic FDA data

COMFYCOMBPLUS

Primary DI
00816924020242
Brand
COMFYCOMBPLUS
Company
Tensproducts, LLC
Model
COMFYCOMBOPLUS
Catalog number
COMFYCOMBOPLUS, COMFYCOMBOPLUS-JETT, COMFYCOMBOPLU
Device description
DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS
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
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
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
00816924020372PackageGS11In Commercial Distribution
00816924020730PackageGS11In Commercial Distribution
00816924020778PackageGS11In Commercial Distribution
10816924020249PackageGS132In Commercial Distribution
10816924020775PackageGS132In Commercial Distribution
00816924020242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816924020372008169240203728169240203720816924020372
00816924020730008169240207308169240207300816924020730
00816924020778008169240207788169240207780816924020778
1081692402024910816924020249
1081692402077510816924020775
00816924020242008169240202428169240202420816924020242

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
00816924020259COMFYEMSCOMFYEMSCOMFYEMS, COMFYEMS-JETT, COMFYEMS-TP, COMFYEMS-MFR2019-11-21
00816924020266COMFYTENSCOMFYTENSCOMFYTENS, COMFYTENS-JETT, COMFYTENS-TP, COMFYTENS2019-11-21
00816924020273PRECISION EMS 6.0EMS6.0EMS6.0, EMS6.0-TP, EMS6.0-MFR2019-11-21
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

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Primary DI, Brand, Company table
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