FDA.reportPublic FDA data

ReActiv8 Programmer

Primary DI
05391527771364
Brand
ReActiv8 Programmer
Company
MAINSTAY MEDICAL LIMITED
Model
6M7500-012
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190021000ReActiv8 Implantable Neurostimulation SystemMainstay Medical Limited2020-06-16QLK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391527771364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391527771364053915277713645391527771364

GMDN Terms#

Term, Definition table
TermDefinition
Implantable electrical stimulation device management softwareA software program intended to assist with the management of an implantable electrical stimulator associated with stimulation of the spinal cord, non-auditory peripheral nerves, brain, and/or muscles; it is not intended to manage hearing assistive implants. It may be intended for use in one or more areas of functionality including: 1) configuration of a variety of electrical pulse parameters (e.g., amplitude, frequency, width) for the provision of periodic electrical stimulation; 2) post-implantation visualization; 3) assessment of programming parameters; 4) collection of patient clinical data.

Regulatory Flags#

DUNS number
985519015
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391527771357ReActiv8 Programmer 6M7500-0112025-05-22
05391527770626ReActiv8 Magnet6M4000-00340002021-01-25
05391527772071ReActiv8 Stimulation Lead7M8145-00681452021-01-25
05391527772279ReActiv8 Stimulation Lead7M8165-00681652021-01-25
05391527770046ReActiv8 IPG7M5100-00551002025-02-13
05391527772804ReActiv8 Release ToolEXT12024-01-22
05391527772415Mainstay Tunneler7MTUN1-002TUN12021-01-25
05391527770633ReActiv8 Magnet6M4000-00440002021-01-25
05391527770213ReActiv8 Programming Wand6M6000-00260002021-01-25
05391527770411ReActiv8 Activator6M7000-00270002021-01-25
05391527772064ReActiv8 Stimulation Lead7M8145-00581452021-01-25
05391527772262ReActiv8 Stimulation Lead7M8165-00581652021-01-25
05391527770015ReActiv8 IPG7M5100-00251002021-01-25
05391527770817ReActiv8 Torque Wrench7M5500-00255002021-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391527771357ReActiv8 Programmer MAINSTAY MEDICAL LIMITEDQLK2025-05-22
05391527770046ReActiv8 IPGMAINSTAY MEDICAL LIMITEDQLK2025-02-13
05391527770015ReActiv8 IPGMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527770213ReActiv8 Programming WandMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527770411ReActiv8 ActivatorMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527770626ReActiv8 MagnetMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527770633ReActiv8 MagnetMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527770817ReActiv8 Torque WrenchMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527772064ReActiv8 Stimulation LeadMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527772071ReActiv8 Stimulation LeadMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527772262ReActiv8 Stimulation LeadMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527772279ReActiv8 Stimulation LeadMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527772415Mainstay TunnelerMAINSTAY MEDICAL LIMITEDQLK2021-01-25