# K102610: Focus Emg Device

- Pathway: 510(k) (Traditional)
- Applicant: Teleemg, LLC USA
- Decided: Mar 4, 2011 after 175 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922488 (1993). 3 ancestors in all.
34 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073415: Nemus System; Nemus PC Peripheral, Eb Neuro S.P.A. (2008) Summary page 1.
- K981405: Synergy LT, Oxford Instruments, Plc. (1998) Summary page 1.

## Most influential descendants
- K112052: Carefusion Nicolet Edx (2012), 30 descendants of its own
- K162383: Cadwell Sierra Summit, Cadwell Sierra Ascent (2017), 12 descendants of its own
- K120979: Carefusion Nicolet Edx (2012), 12 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own

## Indications for use
The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.

Source page: https://510kreport.com/device/K102610
Methodology: https://510kreport.com/methodology