# K081835: Acticare IC and Tse

- Pathway: 510(k) (Traditional)
- Applicant: Bioinduction Limited
- Decided: Mar 19, 2009 after 265 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: 2 generations back to K872657 (1987). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003744: Enraf-Nonius Endomed 182 System, Henley Healthcare, Inc. (2002) Summary page 1.
- K946299: PGS123 and HVS-123, Skylark Device Co., Ltd. (1995) Summary page 1.
- K022405: Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens Device; Promax-Libra, Tens Device; Promax-Mic, Rehabilicare, Inc. (2002) Summary page 1.
- K022731: V Tens Plus, Body Clock Health Care, Ltd. (2002) Summary page 1.
- K010749: Electro Neuromuscular Stimulator, Model NMS-Digital, Biomedical Life Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K161091: STIMPOD NMS460 Nerve Stimulator (2017), 2 descendants of its own
- K252712: STIMPOD NMS460 Nerve Stimulator (2026), 0 descendants of its own
- K213802: StimOnTM Pain Relief System (GM2439) (2022), 0 descendants of its own

## Indications for use
As a Transcutaneous Electronic Nerve Stimulation (TENS) device for: the symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical or post-traumatic pain. As a Neuromuscular Electrostimulation (NMES) device for: the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis and to maintain or increase the range of motion.

Source page: https://510kreport.com/device/K081835
Methodology: https://510kreport.com/methodology