FDA.reportPublic FDA data

FREMSLIFE

Primary DI
08055765540003
Brand
FREMSLIFE
Company
FREMSLIFE SRL
Model
APTIVA 4
Catalog number
905-000-004
Published
2018-01-28
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
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
HCCDevice, Biofeedback
IKNElectromyograph, Diagnostic
JXEDevice, Nerve Conduction Velocity Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
HCCDevice, BiofeedbackNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
JXEDevice, Nerve Conduction Velocity MeasurementNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061828000LORENZ BIOTECH APTIVA, VERSION 2.13Lorenz Biotech S.P.A.2007-08-24GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055765540003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055765540003080557655400038055765540003

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic peripheral nerve electrical stimulation systemAn assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.

Regulatory Flags#

DUNS number
435784260
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055765540010FREMSLIFEAPTI-GEL 800-000-056800-000-0562018-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.HCC2026-06-04
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
08719481550110NeXus 10 MK3Mind Media Europe B.V.HCC2025-09-10
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
08056446901106NExT-DOCKINGEB NEURO SPAIKN2025-05-22
08056446901113NExT-PADEB NEURO SPAIKN2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAIKN2025-05-22
08056446901137NExT-HSEB NEURO SPAIKN2025-05-22
08056446901168NExT-AMPEB NEURO SPAIKN2025-05-22
08056446901199NExT-ASEB NEURO SPAIKN2025-05-22
08056446901205NExT StationEB NEURO SPAIKN2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAIKN2025-05-19
50885380198791KangarooCardinal Health 200, LLCHCC2025-03-12
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
10853818007504USB C AdapterPRECISION BIOMETRICS INCHCC2024-09-03
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
50885380195554NTRAINERCardinal Health 200, LLCHCC2023-07-03
50885380195561NTRAINERCardinal Health 200, LLCHCC2023-07-03
08051122040902Shoulder Pacemaker deviceNCS LAB SRLHCC2021-09-01
08051122040919Shoulder Pacemaker device (wireless PC)NCS LAB SRLHCC2021-09-01
08051122040926MySPM AppNCS LAB SRLHCC2021-09-01
08051122040933MySPM@Home AppNCS LAB SRLHCC2021-09-01
08051122040940Stand-alone mode KitNCS LAB SRLHCC2021-09-01