FDA.reportPublic FDA data

Neuroprobe 500 Pro

Primary DI
00858703006054
Brand
Neuroprobe 500 Pro
Company
ACCELERATED CARE PLUS CORP
Model
140500B
Device description
The Neuroprobe® 500 Pro gives the clinician the option of using any combination of an Estim probe, Interferential Currentin bipolar or quadripolar modes, or Monochromatic Infrared Therapy to reduce pain and increase circulation.Flexible neoprene pads deliver heat and Infrared therapy through multiple clusters of infrared and red visible superluminous diodes (SLD).The Neuroprobe® 500 Pro’s optional probe with fully adjustable parameters provides a wide variety of uses for painmanagement with trigger point stimulation for pain control.The Neuroprobe® 500 Pro provides a nerve block mode through treatment pads with high output capable of sensorynerve block, or through the optional probe to produce local trigger point anesthesia.
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K831147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831147000OMNIPROBE ELECTRICAL NERVE STIMULATOROmni Intl., Inc.1983-07-18GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858703006051PackageGS14In Commercial Distribution
00858703006054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085870300605110858703006051
00858703006054008587030060548587030060540858703006054

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-350-1100customersupport@acplus.com

Regulatory Flags#

DUNS number
828331616
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858703006252Ultraphonic (250ml Bottle)455392016-09-06
00858703006269Ultraphonic, 5 Liter w/ bottle320602016-09-06
00858703006061Omnipad Light Therapy, Dual 5x7 Pads768962016-08-16
00858703006399OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise SystemA007-5332024-10-21
00858703006382OmniTour System300800T2024-09-10
00858703006207Synchrony Oro-Facial sEMG Electrode618792016-08-16
00858703006214Electrodes Pharyngeal sEMG341842016-08-16
00858703006375OmniTourOmniTourSoftware2023-09-12
00858703006313OmniFlow SoftwareFlowSoftware2023-09-06
00858703006092OmniStim FX2 Portable PENS300200A-12016-08-16
00858703006276OmniFlow Therapy System100FLO2023-09-12
00858703006344ACPlus Respiratory AssessmentARASoftware2023-09-12
00858703006368ACPlus Platform100ACPLUS2023-09-12
B179OMNI13E87E4OmnisEMG441442023-09-06
00858703006337Synchrony Dysphagia Solutions by ACP300800A2023-09-01
00858703006351OmniVR Elite300600C2023-09-01
00858703006139OmniVersa100FXF2023-08-17
00858703006320OmniME100MTS2023-08-17
00858703006078Megapulse II19030292016-08-16
00858703006122Omnistim FX2 Continence Plus Portable300100A2016-08-16

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