# K232441: Unipro (K-UNIPRO-US)

- Pathway: 510(k) (Traditional)
- Applicant: Tenscare, Ltd.
- Decided: Aug 30, 2024 after 382 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: 5 generations back to K994266 (2000). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120054: Ultima Neo, Pain Management Technologies (2012) Summary page 6.

## Most influential descendants
- K252236: CP Relief Wand Rx - TENS/NMES (2025), 0 descendants of its own

## Indications for use
TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain. EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for: » Relaxation of muscle spasm * Increasing local blood circulation and muscle re-education * Prevention or retardation of disuse atrophy * Prevention of venous thrombosis of the calf muscles immediately after surgery * Maintaining on increasing range of motion MIC stands for Microcurrent Stimulation. Unipro MIC is used to provide sumptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain. IFT stands for Interferntial Stimulation. Unipro IFT is indicated for symptomatic relief of chronic intractable pain.

Source page: https://510kreport.com/device/K232441
Methodology: https://510kreport.com/methodology