FDA.reportPublic FDA data

actiTENS Mini

Primary DI
03770018808260
Brand
actiTENS Mini
Company
SUBLIMED
Model
actiTENS Mini
Catalog number
SBM7AA100
Device description
The actiTENS mini medical device is a transcutaneous electrical neurostimulator designed for pain relief. It also contains an electrical muscle strengthening program.The EIG (electrical impulse generator) generates electrical impulses that are diffused in the body through skin electrodes connected to one or two channels via cables available in various lengths. Managing the EIG is done by means of the actiTENS Mobile App that allows users to control the stimulation session by choosing : a stimulation program, the number of channels used, the stimulation intensity for each channel and the stimulation duration.
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
true
Sterile
false
Single use
false

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
K252767000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770018808260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770018808260037700188082603770018808260

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.

Regulatory Flags#

DUNS number
267525498
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
B786SBM2AA1100actiTENSactiTENS Android appSBM2AA1102024-04-24
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
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNUH2026-08-26
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNGX2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNGX2026-08-18
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNUH2026-08-18
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850087184045HomedicsFKA DISTRIBUTING CO., LLCNUH2026-07-31
06924607703550Transcutaneous Electrical Nerve StimulatorsShenzhen Kentro Medical Electronics Co.,LtdNUH2026-07-31
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-29
08032625829843NerveOTXDOMINO SRLGZJ2026-07-28
08032625829843NerveOTXDOMINO SRLIPF2026-07-28
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-25
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
06978146200117SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
00850085485090AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-07-16
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.GZJ2026-07-14
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-07-14
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNYN2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09