FDA.reportPublic FDA data

Clinical Kit, Synchrony

Primary DI
00852184003649
Brand
Clinical Kit, Synchrony
Company
Synapse Biomedical, Inc.
Model
20-3001
Device description
Stimulator, Neuromuscular, External Functional
Published
2025-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional
IPFStimulator, Muscle, Powered
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
KQXGoniometer, Ac-PoweredOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242704000Synchrony (20-3000)Synapse Biomedical, Inc.2025-06-05GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852184003649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852184003649008521840036498521840036490852184003649

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.

Contacts#

Phone, Email table
PhoneEmail
1-888-767-3770customerservice@synapsebiomedical.com

Regulatory Flags#

DUNS number
138432070
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008521840036182 Pack, Electrode Delivery Tool Kit20-00742021-03-16
00852184003007NeuRx Diaphragm Pacing System20-00352014-09-24
00852184003038NeuRx DPS™ Surgical Kit, HDE20-00282014-09-24
00852184003045NeuRx DPS Patient Kit20-00362014-09-24
00852184003090STERILE Mapping Probe21-0001-992014-09-24
00852184003106STERILE Indifferent Electrode21-0004-992014-09-24
00852184003113STERILE Lead Tunnelers21-0007-992014-09-24
00852184003120STERILE Blue Cable Set21-0009-992014-09-24
00852184003137STERILE Trocar to Transducer Tubing21-0010-992014-09-24
00852184003144STERILE PermaLoc Electrode, 60cm21-0017-992014-09-24
00852184003151STERILE Touchproof Cable, Green21-0023-992014-09-24
00852184003168STERILE Touchproof Cable, Orange21-0024-992014-09-24
00852184003175STERILE Touchproof Cable Yellow21-0025-992014-09-24
00852184003182STERILE Touchproof Cable, White21-0026-992014-09-24
00852184003199NeuRx DPS™ Surgical Site Start-up Kit, SCI HDE20-00072014-09-24
00852184003212NeuRx DPS™ External Pulse Generator23-00212014-09-24
00852184003267Spare Surgical Kit20-00402014-09-24
00852184003298System Destination Kit, SCI HDE, US20-00612014-09-24
00852184003342Connector Holder Kit22-00042014-09-24
00852184003366Patient Cable22-00112014-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
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
00810188050083L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050120L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050274L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050069L360 Thigh SystemBioness Medical, Inc.GZI2025-07-17
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050090L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050113L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050137L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050144L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050168L100 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050236L300 Go SystemBioness Medical, Inc.IPF2025-07-17