FDA.reportPublic FDA data

Xcite

Primary DI
FA216218
Brand
Xcite
Company
RESTORATIVE THERAPIES, INC.
Model
Xcite clinical station
Published
2016-12-21
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
GZIStimulator, Neuromuscular, External Functional
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160614000Xcite Clinical StationRestorative Therapies, Inc.2016-12-16IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
FA216218PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit 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. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186976408
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
FA109136RT200RT200-SLSA2016-09-16
FA211762RT200RT200-SLA2016-09-16
SA105419RT300UE FES existing RT300-SL2016-09-16
SA216652RT300RT300 clinic replacement (SLSA to SLSA)2016-09-16
SA217807RT300RT300 clinic replacement (SL to SL)2016-09-16
SA217808RT300RT300 clinic replacement (SL to SLSA)2016-09-16
SA219057RT300RT300 Home Replacement (SLSA to SLSA)2017-03-15
SA219083RT300RT300 Home Replacement (SL to SL)2017-03-15
SA219084RT300RT300 Home Replacement (SL to SLSA)2017-03-15
SA219216RT300RT300 Clinic Replacement (SA to SA)2017-08-10
SA219258RT300RT300 Home Replacement (SLA to SLA)2017-08-10
FA100052RT300RT300-SL2016-09-16
FA102011RT300RT300-SLA2016-09-16
FA104581RT300RT300-SLSA2016-09-16
FA109080RT300RT300-LSA2016-09-16
FA211509RT600RT600-SL2016-09-15
FA216769RT300RT300-SLP2016-09-16
FA216912RT300SAGE stimulator2016-09-16
FA217786RT300RT300-SLA Supine2016-09-16
FA217787RT300RT300-SLSA Supine2016-09-16

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
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