FDA.reportPublic FDA data

ReActiv8 Magnet

Primary DI
05391527770633
Brand
ReActiv8 Magnet
Company
MAINSTAY MEDICAL LIMITED
Model
6M4000-004
Catalog number
4000
Device description
ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming).
Published
2021-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
05391527770633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391527770633053915277706335391527770633

GMDN Terms#

Term, Definition table
TermDefinition
Implantable stimulator control magnetA hand-operated, non-sterile, magnetic device designed to be used by a patient to switch an implanted stimulator (e.g., a neurostimulator that can be controlled by a strong external magnetic force) on and off. It typically consists of a small portable magnet (e.g., strontium ferrite) coated with an epoxy that can be carried in the pocket or a handbag (purse) of a patient for convenient access. It is placed by the patient against the skin directly over the site of the implanted stimulator and turned as prescribed by the manufacturer to affect the stimulator. This is a reusable device.

Sterilization Methods#

Method table
Method

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
05391527771364ReActiv8 Programmer 6M7500-0122025-05-22
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
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
05391527771364ReActiv8 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
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