# K071969: Sen-4100 Electric Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Oct 6, 2008 after 447 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020400 (2002). 1 ancestor in all.
14 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020400: Digitimer D185 Multipulse Cortical Stimulator, Meps, LLC (2002) Summary page 1.

## Most influential descendants
- K110410: MS-120BK Electric Stimulator (Extension Unit) (2011), 13 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K213849: SafeOp 2: Neural Informatix System (2022), 4 descendants of its own
- K234092: SafeOp 3: Neural Informatix Systeem (2024), 3 descendants of its own
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own

## Indications for use
Nihon Kohden Sen-4100 Electric Stimulator is used for the intraoperative diagnosis of acute dysfunction in corticospinal tract axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

Source page: https://510kreport.com/device/K071969
Methodology: https://510kreport.com/methodology