# K120054: Ultima Neo

- Pathway: 510(k) (Abbreviated)
- Applicant: Pain Management Technologies
- Decided: Jun 5, 2012 after 151 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: 4 generations back to K994266 (2000). 14 ancestors in all.
2 later devices descend 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)
- K050921: Easystim NMS-28, Easy Med Instrument Co., Ltd. (2005) Summary page 2.
- K093138: MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003, Shenzhen Dongdixin Technology Co., Ltd. (2010) Summary page 2.
- K032719: GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing), Gemore Technology Co, Ltd. (2003) Summary page 2.

## Most influential descendants
- K232441: Unipro (K-UNIPRO-US) (2024), 1 descendant of its own
- K252236: CP Relief Wand Rx - TENS/NMES (2025), 0 descendants of its own

## Indications for use
TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain. EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system 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 or increasing range of motion. MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain. IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for: *Symptomatic relief of chronic intractable pain.

Source page: https://510kreport.com/device/K120054
Methodology: https://510kreport.com/methodology