FDA.reportPublic FDA data

Prelivia

Primary DI
17540176050091
Brand
Prelivia
Company
Rehabtronics Inc
Model
PR-IES1A
Device description
The Prelivia System is a portable transcutaneous muscle stimulation system intended to increase regional blood circulation at stimulated treatment areas, and to reduce the incidence and progression of pressure ulcers (bed sores) in individuals who are immobile due to their clinical condition.
Published
2024-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210979000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210979000PreliviaRehabtronics, Inc.2021-05-13IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540176050091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754017605009117540176050091

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243936569
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17540176010033ReJoyceRV102019-07-02
17540176050107Prelivia ElectrodePR-EL1APR-IES1A2024-11-12
17540176050114Prelivia ElectrodePR-EL1AbPR-IES1A2024-11-12
17540176030147ReGraspHSEPKV22024-02-23
17540176030154ReGraspHSEPKBC2024-02-23
17540176030161ReGraspEPKL-S2024-02-23
17540176030178ReGraspEPKL-M2024-02-23
17540176030185ReGraspEPKL-L2024-02-23
17540176030192ReGraspEPKTS2024-02-23
17540176030208ReGraspEPKPN2024-02-23
17540176030215ReGraspEPKGE-L2024-02-23
17540176030222ReGraspEPKGE-S2024-02-23
17540176030239ReGraspEPKCE-L2024-02-23
17540176030246ReGraspEPKCE-S2024-02-23
17540176030253ReGraspHSEP22024-02-23
17540176050039Prelivia LeadsPR-LEAD1PR-LEAD12021-10-04
17540176050046Prelivia Lead BulkPR-LEAD1BPR-LEAD1B2021-10-04
17540176050008PreliviaPR-IES12021-10-01
17540176050022Prelivia ElectrodesPR-IES1PR-IES12021-10-01
17540176030123ReGraspHSEPK12020-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.IPF2026-06-04
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
00816864021682accufitMETTLER ELECTRONICS CORP.IPF2026-04-22
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
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.IPF2025-07-18
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050144L300 Go SystemBioness Medical, Inc.IPF2025-07-17