FDA.reportPublic FDA data

ReActiv8 IPG

Primary DI
05391527770015
Brand
ReActiv8 IPG
Company
MAINSTAY MEDICAL LIMITED
Model
7M5100-002
Catalog number
5100
Device description
ReActiv8 Implantable Pulse Generator
Published
2021-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
05391527770015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391527770015053915277700155391527770015

GMDN Terms#

Term, Definition table
TermDefinition
Implantable lumbar neuromuscular electrical stimulation system pulse generatorA sterile, implantable, electronic component of an implantable lumbar neuromuscular electrical stimulation system intended to deliver episodic electrical stimulation to nerves that innervate lumbar muscles to elicit contraction for the treatment of chronic low back pain (CLBP). It is a battery-powered electrical pulse generator, typically implanted in a subcutaneous pocket in the low back region, which has connections for electrical leads (not included). The device is programmed, controlled and charged telemetrically by external devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-702-8488info@mainstay-medical.com

Regulatory Flags#

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