FDA.reportPublic FDA data

KONMED /Pelvifine

Primary DI
06970935830543
Brand
KONMED /Pelvifine
Company
Shenzhen Konmed Technology Co., Ltd.
Model
KM531
Device description
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Published
2021-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback
IPFStimulator, Muscle, Powered
KPIStimulator, Electrical, Non-Implantable, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
KPIStimulator, Electrical, Non-Implantable, For IncontinenceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202648000Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd.2020-12-08IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970935830543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970935830543069709358305436970935830543

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic floor exercise biofeedback deviceAn electrically-powered, home-use device intended to be inserted into the anus to visualize/measure the consciously-controlled contraction force of the pelvic floor muscles, to facilitate the self-training of pelvic floor exercises for improved control of bowel function in patients affected by anal/faecal incontinence and/or constipation; it is not a muscle exerciser. It may wirelessly transmit data to a smartphone app for display/recording. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544436531
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970935830529KONMED /PelvifineKM508B2025-09-30
06970935830710PelvifineKM5002025-02-18
06970935830536KONMED /PelvifineKM5302021-10-25
06970935830482KONMEDKM-5022024-03-05
06970935830499KONMEDKM-5032024-03-05
06970935830642KONMEDKM-5042024-03-05
06970935830659KONMEDKM-5052024-03-05
06970935830666KONMEDKM-5062024-03-05
06970935830673KONMEDKM-5072024-03-05
06970935830680KONMEDKM-50132024-03-05
06970935830697KONMEDKM-50182024-03-05
06970935830567KONMED /PelvifineKM530B2022-08-24
06970935830574KONMED /PelvifineKM531B2022-08-24
06970935830581KONMED /PelvifineKM5362022-08-24
06970935830598KONMED /PelvifineKM5372022-08-24
06970935830079KonmedKM-8032018-01-25
06970935830086KonmedKM-8082018-01-25
06970935830093KonmedKM-8012018-01-25
06970935830109KonmedKM-8022018-01-25
06970935830116KonmedKM-8062018-01-25

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
00816271020377NoraxonNoraxon U.S.A., Inc.HCC2026-03-30
00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020414UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020421UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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
08719481550110NeXus 10 MK3Mind Media Europe B.V.HCC2025-09-10
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