actiTENS
- Primary DI
- B786SBM2AA2100
- Brand
- actiTENS
- Company
- SUBLIMED
- Model
- actiTENS iOS app
- Catalog number
- SBM2AA210
- Device description
- actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. 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.
- 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#
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 2 |
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 2 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 2 |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | Neurology | 2 |
Premarket Submissions#
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B786SBM2AA2100 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Analgesic transcutaneous electrical nerve stimulation system | An 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 |
|---|
Regulatory Flags#
- DUNS number
- 267525498
- Device count
- 1
- Serial number
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 03770018808086 | actiTENS | Belt/Bra accessory | SBM1AG400 | 2026-05-27 |
| 03770018808093 | actiTENS | actiTENS armband - 40 cm | SBM1AG300 | 2026-05-27 |
| 03770018808109 | actiTENS | actiTENS armband - 70 cm | SBM1AG301 | 2026-05-27 |
| 03770018808116 | actiTENS | actiTENS armband - 130 cm | SBM1AG302 | 2026-05-27 |
| 03770018808253 | actiTENS Mini | actiTENS Mini KIT | SBM7AA011 | 2026-05-27 |
| 03770018808260 | actiTENS Mini | actiTENS Mini | SBM7AA100 | 2026-05-27 |
| B786SBM2AA1100 | actiTENS | actiTENS Android app | SBM2AA110 | 2024-04-24 |
| 03770018808239 | actiTENS | actiTENS standard kit | SBM1AA018 | 2025-02-07 |
| B786SBM1AA0170 | actiTENS | actiTENS standard kit | SBM1AA017 | 2024-04-24 |
| B786SBM1AA1100 | actiTENS | actiTENS | SBM1AA110 | 2024-04-24 |
| B786SBM1AB0110 | actiTENS | actiTENS self-adhesive strips | SBM1AB011 | 2024-04-24 |
| B786SBM1AF1100 | actiTENS | Charging case | SBM1AF110 | 2024-04-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06971712725359 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-09 |
| 06971712725359 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-07-09 |
| 06971712725359 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | GZJ | 2026-07-09 |
| 06971712725359 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | IPF | 2026-07-09 |
| 06971712725359 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NYN | 2026-07-09 |
| 06971712722693 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NYN | 2026-07-09 |
| 06971712722693 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | IPF | 2026-07-09 |
| 06971712722693 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | GZJ | 2026-07-09 |
| 06971712722693 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-07-09 |
| 06971712722693 | DOMAS | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-09 |
| 00850080988572 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-07-03 |
| 00850080988572 | AUVON | UAN HEALTHCARE LIMITED | NGX | 2026-07-03 |
| 06971712727636 | ONENTECH | Hong Qiangxing (Shen Zhen) Electronics Limited | NGX | 2026-07-03 |
| 06971712727636 | ONENTECH | Hong Qiangxing (Shen Zhen) Electronics Limited | GZJ | 2026-07-03 |
| 06971712727636 | ONENTECH | Hong Qiangxing (Shen Zhen) Electronics Limited | IPF | 2026-07-03 |
| 06971712727636 | ONENTECH | Hong Qiangxing (Shen Zhen) Electronics Limited | NUH | 2026-07-03 |
| 06978452680122 | AUVON | Shenzhen Jiantuo Electronics Co., Ltd | NGX | 2026-07-01 |
| 06978452680122 | AUVON | Shenzhen Jiantuo Electronics Co., Ltd | NUH | 2026-07-01 |
| 00850085485021 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NUH | 2026-06-26 |
| 00850085485021 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NGX | 2026-06-26 |
| 00850085485038 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NGX | 2026-06-26 |
| 00850085485038 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NUH | 2026-06-26 |
| 00850085485045 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NGX | 2026-06-26 |
| 00850085485045 | AUVON | Ansion Technology (GuangDong) Co. Ltd. | NUH | 2026-06-26 |
| 00850085485007 | AVCOO | Ansion Technology (GuangDong) Co. Ltd. | NGX | 2026-06-25 |
| 00850085485007 | AVCOO | Ansion Technology (GuangDong) Co. Ltd. | NUH | 2026-06-25 |
| 00850080988473 | AUVON | UAN HEALTHCARE LIMITED | NUH | 2026-06-24 |
| 00850080988473 | AUVON | UAN HEALTHCARE LIMITED | NGX | 2026-06-24 |
| 08809851470145 | Wavefacial | WEERO Co., Ltd. | IPF | 2026-06-22 |
| 08809851470145 | Wavefacial | WEERO Co., Ltd. | GZJ | 2026-06-22 |