FDA.reportPublic FDA data

BiowavePRO

Primary DI
00859911006065
Brand
BiowavePRO
Company
BIOWAVE CORPORATION
Model
BWPD01
Device description
BioWavePRO Neurostimulator
Published
2016-08-01
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
NHIStimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061166000DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEMBiowave Corporation2006-08-15NHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859911006065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911006065008599110060658599110060650859911006065

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic percutaneous electrical nerve stimulation systemAn assembly of mains electricity (AC-powered) devices intended for the relief of chronic neuropathic pain through percutaneous electrical nerve stimulation (PENS). It typically consists of external current generator, return electrode(s), connection cables and a system probe which may be provided separately. It is intended to deliver controlled electrical impulses directly to the subcutaneous tissue (i.e., invasively) in the vicinity of a peripheral nerve. It is intended to be used by a healthcare professional in a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-246-9283info@biowave.com

Regulatory Flags#

DUNS number
005759084
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859911006140BioWave Noninvasive ElectrodesGOPADS_12023-08-07
00859911006232BioWave Silver Back BioWrap S/MBWRPSILVER-BACK-SM2023-08-07
00859911006249BioWave Silver Knee BioWrap S/MBWRPSILVER-KNEE-SM2023-08-07
00859911006256BioWave Silver Foot-Ankle BioWrap S/MBWRPSILVER-FOOT-ANKLE-SM2023-08-07
00859911006461BioWave Silver Back BioWrap L/XLBWRPSILVER-BACK-LXL2023-08-07
00859911006492BioWave Silver Foot-Ankle BioWrap L/XLBWRPSILVER-FOOT-ANKLE-LXL2023-08-07
00859911006508BioWave Silver Knee BioWrap L/XLBWRPSILVER-KNEE-LXL2023-08-07
00859911006546BioWave Silver Thigh-Calf BioWrap S/MBWRPSILVER-THIGH-CALF-SM2023-08-07
00859911006560BioWave Silver Thigh-Calf BioWrap L/XLBWRPSILVER-THIGH-CALF-LXL2023-08-07
00859911006577BioWave BLUE Back BioWrap L/XLBWRPBLUE-BACK-LXL2023-08-07
00859911006584BioWave BLUE Back BioWrap S/MBWRPBLUE-BACK-SM2023-08-07
00859911006591BioWave BLUE Knee BioWrap L/XLBWRPBLUE-KNEE-LXL2023-08-07
00859911006607BioWave Noninvasive Velcro Backed Electrodes - B-SetBIOWRAP-PADS2023-08-07
00859911006669BioWave BLUE Knee BioWrap S/MBWRPBLUE-KNEE-SM2023-08-07
00859911006430BioWaveGO RXBWG-RX2023-06-15
00859911006010BioWaveGOBWG-S2021-07-26
00859911006072BiowaveHOMEBWHD012016-08-01
00859911006089Biowave Noninvasive ElectrodesMK78560 - BWEN01-B2016-08-01
00859911006096Biowave Noninvasive ElectrodesMK78570 - BWEN02-E2016-08-01
00859911006102Biowave Noninvasive ElectrodesMK78580 - BWEN03-U2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908006064328POSP DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-05-22
00850022775260SPRINTSPR THERAPEUTICS, INC.NHI2026-05-19
08908006064199Primary Relief NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
08908006064212NociRelief NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
08908006064236NS100NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
08908006064267ANSiSTIM - PP NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
00850022775000SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775017SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775222SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775239SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775246SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775253SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775376SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775383SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775444SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775451SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775468SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775475SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775482SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775499SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775505SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775512SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775529SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775536SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775543SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775550SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775413SPRINTSPR THERAPEUTICS, INC.NHI2025-08-21
08908006064250NEUMONANEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2025-08-18
08908006064168POSP Device NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2025-05-19
00850022775390SPRINTSPR THERAPEUTICS, INC.NHI2024-08-30