OMNIsEMG 1.0
by Bts SpA
OMNIsEMG 1.0 (BTSEMB1BM) is a Class II device made by Bts SpA, listed in FDA GUDID since 12 Feb 2017 (UDI-DI B179OMN), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB179OMN | Date12 Feb 2017 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- OMNIsEMG
- Generic name
- Electromyograph
- Model / Ref / Catalog
- 1.0, BTSEMB1BM
- Primary DI / UDI-DI
- B179OMN
- FDA product code
- HCC
- GMDN term
- Electromyograph
- Device class
- Class II
- Regulation number
- 882.5050
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HCC (Device, Biofeedback).
- AT53 DUAL CHANNEL EMG by Stoelting Co.
- CALMSET 3 TM by THOUGHT TECHNOLOGY LTD.
- NORODYN 2000 ELECTROMYOGRAPH by Noromed, Inc.
- PHYSIOTECH 4000 OR NORODYN 8000 by Myo-Tronics, Inc.
- PATHWAY II ELECTROMYOGRAPH by THE PROMETHEUS GROUP
- Relax-a-Tone by Bio Response
- Resperate Model RR-150 by Intercure, Ltd.
- TT-EEG MONO/BIPOLAR ELECTRODE KIT T8750 by Thought Technology Ltd.
- DC-EEG TWO CHANNEL CONNECTIVIT KIT T8785 by Thought Technology Ltd.
- Myoexorciser II Fual by Verimed Holdings, Inc.