# K092448: Hivox Electric Stimulator Tens & Ems, HD2

- Pathway: 510(k) (Traditional)
- Applicant: Hivox Biotek, Inc.
- Decided: Mar 30, 2010 after 232 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 K010782 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082514: Tens/Ems Combo, Ems, Tens, Medihightec Medical Co., Ltd. (2008) Summary page 1.

## Indications for use
The TENS programs of HIVQX Electric Stimulator TENS & EMS, HD2: The device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems. The EMS programs of HIVOX Electric Stimulator TENS & EMS, HD2: The device is an electrical powered muscle stimulator indicated for medical purpose to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy.

Source page: https://510kreport.com/device/K092448
Methodology: https://510kreport.com/methodology