| K-number | K252767 |
| Device name | actiTENS mini |
| Applicant | Sublimed |
| Product code | GZJ |
| Device class | Class II |
| Decision date | Jan 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.5890 |
The actiTENS mini is a wearable, battery-powered electrical nerve stimulator device intended for transcutaneous electrical nerve stimulation (TENS) to provide symptomatic relief of chronic pain, post-surgical pain, muscle soreness, and arthritis pain. It also includes an electrical muscle stimulation (EMS) mode for muscle relaxation and rehabilitation. The device is controlled via a mobile app and can be used both over-the-counter and by prescription.
The actiTENS mini delivers compensated asymmetrical biphasic waveforms with a maximum output of 60V and 60mA (0.222W power output) via 2 alternating channels using regulated current control. It features 15 programmable stimulation programs with adjustable frequency (1–120 Hz), pulse width (47–398 µs), and session duration (10–720 minutes). The device includes impedance monitoring, automatic no-load detection, and 10-minute auto-shutoff, with control via Bluetooth-enabled mobile app.
ISO 14971, ISO 15223-1, IEC 60601-1/1-2/1-6/1-11/2-10, IEC 62304, IEC 62366-1, ISO 10993-1/5/10/12, ASTM F2503-23e1, AAMI ANSI NS4, UL 1642/1969/794, IEEE ANSI C63.27-2021, ASTM D4169-23, and others.
The actiTENS mini is substantially equivalent to predicate devices K202159 (actiTENS) and K182203 (JKH Stimulator Plus) based on identical indications for use, similar electrical specifications and waveform characteristics, equivalent biocompatibility, and comparable nonclinical benchtop performance testing. Minor differences in battery configuration and power output do not impact safety or effectiveness, as the device remains within the safe ranges established for TENS/EMS devices.
View the full FDA submission: accessdata.fda.gov