# K080661: Models Tens 7000, Ems 7500 and Twin Stim

- Pathway: 510(k) (Traditional)
- Applicant: Koalaty Products, Inc.
- Decided: Mar 24, 2008 after 14 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020749: Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens, Everyway Medical Instruments Co.,Ltd (2002) Summary page 1.
- K071951: Comfy Series: EV-804, EV-805 & EV-806, Everyway Medical Instruments Co.,Ltd (2007) Summary page 1.

## Most influential descendants
- K123642: Muscle Stimulation System (2013), 1 descendant of its own
- K150742: Muscle Stimulation System 110 (2015), 0 descendants of its own

## Indications for use
APPLICABLE FOR TENS 7000 AND TWIN STIM: 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 EMS 7500 and TWIN STIM: 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/K080661
Methodology: https://510kreport.com/methodology