# K011823: Biorehab System

- Pathway: 510(k) (Abbreviated)
- Applicant: Nicolet Biomedical, Inc.
- Decided: Sep 6, 2001 after 87 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- 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 K854277 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960508: Pathway Electromyograph Model Pathway II/MR-10/MR-15/MR-20/MR-25, The Prometheus Group (1997) Summary page 1.
- K935853: Emg Trainer, Unitech (1995) Summary page 1.
- K854277: Neuropath 4000, Therapeutic Technologies, Inc. (1986) Summary page 1.

## Indications for use
The BioRehab System is used for electromyography (EMG) biofeedback support of relaxation and muscle reeducation. The BioRehab System may be used by licensed medical practitioners to support their methods of muscle relaxation and reeducation/rehabilitation. The BioRehab System can be used in hospital, physician office, clinics, long-term patient care facilities, home and other therapy locations.

Source page: https://510kreport.com/device/K011823
Methodology: https://510kreport.com/methodology