# K082514: Tens/Ems Combo, Ems, Tens

- Pathway: 510(k) (Traditional)
- Applicant: Medihightec Medical Co., Ltd.
- Decided: Oct 21, 2008 after 49 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: 3 generations back to K010782 (2001). 5 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071951: Comfy Series: EV-804, EV-805 & EV-806, Everyway Medical Instruments Co.,Ltd (2007) Summary page 1.

## Most influential descendants
- K100117: LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator (2010), 4 descendants of its own
- K102014: Tens Stimulator, Models 2800 and 3000 (2010), 3 descendants of its own
- K133779: CP Relief Wand (2014), 1 descendant of its own
- K252236: CP Relief Wand Rx - TENS/NMES (2025), 0 descendants of its own
- K113544: Electronic Pulse Massager Tens Electronic Pulse Massager (2012), 0 descendants of its own

## Indications for use
APPLICABLE FOR MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8200 (TENS) AND MH6200 (TENS): This 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 and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems. APPLICABLE FOR MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8l00 (EMS) AND MH6l00 (EMS): This device is an electrically powered muscle stimulator indicated for use for medical purposes 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/K082514
Methodology: https://510kreport.com/methodology