DE-2.1 Differential EMG Sensor SP-E09
by Delsys, Inc.
DE-2.1 Differential EMG Sensor SP-E09 is a Class II device made by Delsys, Inc., cleared under FDA 510(k) K990356 on 29 Apr 1999 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00851679007032), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851679007032 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK990356 | Date29 Apr 1999 | StatusActive |
Official records
- AccessGUDID record 00851679007032
- FDA 510(k) database K990356
Across registries
- FDA 510(k) K990356 decided 29 Apr 1999 Active
- FDA GUDID UDI-DI 00851679007032 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K990356
- Listed FDA GUDID 00851679007032
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DE-2.1 Differential EMG Sensor
- Generic name
- Biofeedback system
- Model / reference
- SP-E09
- Primary DI / UDI-DI
- 00851679007032
- 510(k) Number
- FDA product code
- HCC
- GMDN term
- Biofeedback system
- 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).
- BIOREHAB SYSTEM by Nicolet Biomedical, Inc.
- EMG-UT 30 by American Scientific Corp.
- APOLLO HEART RATE INDICATOR by Key Tronic Corp.
- REGAIN DESKTOP by SRS Medical Systems, Inc.
- POLYGRAM NET BIOFEEDBACK APPLICATION by MEDTRONIC VASCULAR, INC.
- MyOnyx Mobile App SA9030 by Thought Technology Ltd.
- RELAX STRESS REDUCTION SYS by Synapse Software Corp.
- PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421 by Self Regulation Systems, Inc.
- MODEL MES-9000/EMG SYSTEM by MYOTRONICS-NOROMED, INC.
- BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE by Brainmaster