# K210674: Shoulder Pacemaker

- Pathway: 510(k) (Traditional)
- Applicant: Ncs Lab Srl
- Decided: Aug 24, 2021 after 172 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). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 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 4.
- K153696: Chattanooga Revolution Wireless, Djo, LLC (2016) Summary page 4.

## Most influential descendants
- K220994: Shoulder PacemakerTM (2022), 0 descendants of its own

## Indications for use
Shoulder PacemakerTM is an electrotherapy device intended for neuromuscular electrical stimulation (NMES). The Indications for Use for Shoulder PacemakerTM are: - Prevention or retardation of disuse atrophy; - Muscle re-education; - Maintaining or increasing range of motion. The device is intended for adults only.

Source page: https://510kreport.com/device/K210674
Methodology: https://510kreport.com/methodology