# K252767: actiTENS mini

- Pathway: 510(k) (Traditional)
- Applicant: Sublimed
- Decided: Jan 16, 2026 after 140 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K881114 (1988). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202159: actiTENS, Sublimed (2020) Summary page 6.
- K182203: JKH Stimulator Plus, Jkh USA, LLC (2019) Summary page 6.

## Indications for use
Over-the-counter use : actiTENS Mini is intended to be used as: Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: -Symptomatic relief and management of chronic, intractable pain -Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities -Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode. Prescription use: actiTENS Mini is intended to be used as: Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: -Symptomatic relief and management of chronic, intractable pain -Adjunctive treatment for post-surgical and post-trauma acute pain -Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities -Relief of pain associated with arthritis Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode. Electrical Muscle Stimulation (EMS), used for the following indications: -Temporary relaxation of muscle spasms -Prevent or retard disuse atrophy -Increase of local blood flow in the treatment area -Re-educate muscles -Maintain or increase the range of motion -Prevention of venous thrombosis of the calf muscles immediately after surgery Program P9 corresponds to EMS mode.

Source page: https://510kreport.com/device/K252767
Methodology: https://510kreport.com/methodology