actiTENS

Primary DI
B786SBM2AA1100
Brand
actiTENS
Company
SUBLIMED
Model
actiTENS Android app
Catalog number
SBM2AA110
Device description
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.It is available for prescription only.
Published
2024-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202159000
K252767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202159000actiTENSSublimed2020-12-22GZJ
K252767000actiTENS miniSublimed2026-01-16GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B786SBM2AA1100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
267525498
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770018808086actiTENSBelt/Bra accessorySBM1AG4002026-05-27
03770018808093actiTENSactiTENS armband - 40 cmSBM1AG3002026-05-27
03770018808109actiTENSactiTENS armband - 70 cmSBM1AG3012026-05-27
03770018808116actiTENSactiTENS armband - 130 cmSBM1AG3022026-05-27
03770018808253actiTENS MiniactiTENS Mini KITSBM7AA0112026-05-27
03770018808260actiTENS MiniactiTENS MiniSBM7AA1002026-05-27
B786SBM2AA2100actiTENS actiTENS iOS appSBM2AA2102024-04-24
03770018808239actiTENSactiTENS standard kitSBM1AA0182025-02-07
B786SBM1AA0170actiTENSactiTENS standard kit SBM1AA0172024-04-24
B786SBM1AA1100actiTENSactiTENS SBM1AA1102024-04-24
B786SBM1AB0110actiTENSactiTENS self-adhesive stripsSBM1AB0112024-04-24
B786SBM1AF1100actiTENSCharging caseSBM1AF1102024-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808086actiTENSSUBLIMEDNYN2026-05-27
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDNYN2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDNYN2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDNYN2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDNYN2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27