# K210604: Intellihab System

- Pathway: 510(k) (Traditional)
- Applicant: Cymedica Orthopedics, Inc.
- Decided: Jun 3, 2021 after 94 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: 7 generations back to K010335 (2001). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163067: CyMedica e-vive™ System; CY-1000, Cymedica Orthopedics, Inc. (2016) Summary page 13.

## Most influential descendants
- K220738: Motive Knee Wrap (2022), 0 descendants of its own

## Indications for use
The Intellihab system is intended to strengthen the quadricep muscle using powered muscle stimulation to provide symptomatic temporary pain relief associated with knee osteoarthritis and improvement of the knee joint mobility when the recommended treatment regimens are followed. In addition, the Intellihab System is indicated for the following: • Retardation or prevention of disuse atrophy • Evaluation of joint mobility by measuring and recording range of motion The Intellihab System is indicated for adults of 22 years of age and older.

Source page: https://510kreport.com/device/K210604
Methodology: https://510kreport.com/methodology