FDA.reportPublic FDA data

Relivion

Primary DI
07290018393017
Brand
Relivion
Company
NEUROLIEF LTD
Model
PAD0001A
Device description
Electrode Pad Set
Published
2021-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCCStimulator, Nerve, Electrical, Transcutaneous, For MigraineNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212106000RelivionNeurolief , Ltd.2021-08-02PCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290018393014PackageGS110In Commercial Distribution
07290018393017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001839301417290018393014
07290018393017072900183930177290018393017

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive skin pad, single-useA noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.

Regulatory Flags#

DUNS number
600484465
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018393000RelivionRLV32021-12-05
07290018393130Relivion MG PMI Physician InterfaceRLV-PMI-1012021-12-19
07290018393147Relivion MG AppRLV-PMI-1022021-12-19
17290018393113RelivionRLV32021-12-05
17290018393014RelivionPAD0001A2021-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800051500502ELEXIR 2.0Nu Eyne Co., Ltd.PCC2026-04-27
00850045950149EnsoHinge Health, Inc.PCC2026-04-24
08800020403032DOOPANGYbrain Inc.PCC2026-03-10
06971760280138HeadaTermWAT Medical Technology Inc.PCC2025-08-22
16971760280005HeadaTermWAT Medical Technology Inc.PCC2025-08-22
00023601261007AccuReliefDrive Devilbiss HealthcarePCC2024-12-17
30023601261008AccuReliefCOMPASS HEALTH BRANDS CORP.PCC2024-12-17
00092237626658TENS 7000Drive Devilbiss HealthcarePCC2024-10-30
30092237626659TENS 7000COMPASS HEALTH BRANDS CORP.PCC2024-10-30
08800051500199ELEXIRNu Eyne Co., Ltd.PCC2023-08-04
05425018850280Cefaly®Cefaly Technology SPRLPCC2022-12-22
05425018850297Cefaly®Cefaly Technology SPRLPCC2022-12-22
05425018850334Cefaly®Cefaly Technology SPRLPCC2022-12-22
06971760285003HeadaTermWAT Medical Technology Inc.PCC2022-08-23
16971760285000HeadaTermWAT Medical Technology Inc.PCC2022-08-23
07290018393130Relivion MG PMI Physician InterfaceNEUROLIEF LTDPCC2021-12-19
07290018393147Relivion MG AppNEUROLIEF LTDPCC2021-12-19
07290018393000RelivionNEUROLIEF LTDPCC2021-12-05
17290018393113RelivionNEUROLIEF LTDPCC2021-12-05
17290018393014RelivionNEUROLIEF LTDPCC2021-12-05
06971760280022HeadaTermWAT Medical Technology Inc.PCC2021-11-30
05425018850303Cefaly®Cefaly Technology SPRLPCC2021-07-13
05425018850310Cefaly®Cefaly Technology SPRLPCC2021-07-13
05425018850174Cefaly®Cefaly Technology SPRLPCC2021-07-13
05425018850181Cefaly®Cefaly Technology SPRLPCC2021-07-13
05425018850273Cefaly®Cefaly Technology SPRLPCC2021-05-17
08800051500021ALLIVENu Eyne Co., Ltd.PCC2021-03-22
05425018850266Cefaly®Cefaly Technology SPRLPCC2017-11-29
05425018850242Cefaly®Cefaly Technology SPRLPCC2017-11-29
05425018850259Cefaly®Cefaly Technology SPRLPCC2017-11-29