# K202159: actiTENS

- Pathway: 510(k) (Traditional)
- Applicant: Sublimed
- Decided: Dec 22, 2020 after 141 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: 8 generations back to K881114 (1988). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182203: JKH Stimulator Plus, Jkh USA, LLC (2019) Summary page 4.

## Most influential descendants
- K252767: actiTENS mini (2026), 0 descendants of its own

## Indications for use
actiTENS 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 and P13 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/K202159
Methodology: https://510kreport.com/methodology