# K153696: Chattanooga Revolution Wireless

- Pathway: 510(k) (Traditional)
- Applicant: Djo, LLC
- Decided: Apr 14, 2016 after 113 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 K945509 (1995). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132284: Vectra Neo Clinical Therapy System, Djo, LLC (2014) Summary page 4.

## Most influential descendants
- K210674: Shoulder Pacemaker (2021), 1 descendant of its own
- K220994: Shoulder PacemakerTM (2022), 0 descendants of its own
- K202186: TrueRelief Device (2021), 0 descendants of its own

## Indications for use
The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional. Indications for Use: As an NMES device, indications are for the following conditions: - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation - Prevention of venous thrombosis of the calf muscles immediately after surgery As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic, intractable pain - Post-surgical and post-trauma acute pain As a pulsed mode device, indications are for the following conditions: - Relaxation of muscle spasm - Increasing local blood circulation - Retardation or prevention of disuse atrophy - Maintenance or increase of range of motion

Source page: https://510kreport.com/device/K153696
Methodology: https://510kreport.com/methodology