# K163067: CyMedica e-vive™ System; CY-1000

- Pathway: 510(k) (Traditional)
- Applicant: Cymedica Orthopedics, Inc.
- Decided: Dec 1, 2016 after 29 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: 6 generations back to K010335 (2001). 19 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150413: QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator, Cymedica Orthopedics, Inc. (2015) Summary page 5.

## Most influential descendants
- K210674: Shoulder Pacemaker (2021), 1 descendant of its own
- K210604: Intellihab System (2021), 1 descendant of its own
- K220994: Shoulder PacemakerTM (2022), 0 descendants of its own
- K220738: Motive Knee Wrap (2022), 0 descendants of its own

## Indications for use
The CyMedica e-vive System is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). Indications for Use: - As an NMES device, indications are for the following conditions: - Relaxation of muscle spasms - Retardation or prevention of disuse atrophy - Increasing local blood circulation - Re-educating muscles - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain

Source page: https://510kreport.com/device/K163067
Methodology: https://510kreport.com/methodology