FDA.reportPublic FDA data

Motor Point Probe, Synchrony

Primary DI
00852184003670
Brand
Motor Point Probe, Synchrony
Company
Synapse Biomedical, Inc.
Model
23-3003
Device description
Stimulator, Neuromuscular, External Functional
Published
2025-10-31
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
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
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
00852184003670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852184003670008521840036708521840036700852184003670

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816271020698UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020803myoRESEARCHNoraxon U.S.A., Inc.KQX2026-03-30
00816271020865UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020872UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021039UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021046UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021053UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021060UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021077UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021084UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021091UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021107UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021114UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021121UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021138UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021145UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00852184003694Electrode Cable, SingleSynapse Biomedical, Inc.GZI2025-10-31
00852184003700Electrode Cable, DualSynapse Biomedical, Inc.GZI2025-10-31
00852184003717Electrode Cable, TripleSynapse Biomedical, Inc.GZI2025-10-31
00852184003724Electrode Cable, Four Synapse Biomedical, Inc.GZI2025-10-31
00852184003762Electrode Cable KitSynapse Biomedical, Inc.GZI2025-10-31
00852184003786Sensor Boot SetSynapse Biomedical, Inc.GZI2025-10-31
00852184003793Sensor Boot - SmallSynapse Biomedical, Inc.GZI2025-10-31
00852184003809Sensor Boot - MediumSynapse Biomedical, Inc.GZI2025-10-31
00852184003816Sensor Boot - LargeSynapse Biomedical, Inc.GZI2025-10-31
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.GZI2025-10-23
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.KQX2025-10-23
00852184003656Stimulator, SynchonySynapse Biomedical, Inc.GZI2025-10-23
00852184003663Sensor, SynchonySynapse Biomedical, Inc.GZI2025-10-23
00852184003687Patient Kit, SynchronySynapse Biomedical, Inc.GZI2025-10-23