DE-2.1 Differential EMG Sensor

FDA UDI

Class II (US FDA UDI)

by Delsys, Inc.

Identity

Trade Name: DE-2.1 Differential EMG Sensor FDA UDI
Generic Name: Biofeedback system FDA UDI
Device Name: Bagnoli System Component FDA UDI
Model / Reference: SP-E09 FDA UDI
Description: Bagnoli System Component FDA UDI

Identifiers

Primary DI / UDI-DI: 00851679007032 FDA UDI
510(k) Number: K990356 FDA UDI
FDA Product Code: HCC FDA UDI
GMDN Term: Biofeedback system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Biofeedback system

DE-2.1 Differential EMG Sensor by Delsys, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biofeedback system.

ONDAMED — ONDAMED INC. · Class II
ONDAMED — ONDAMED INC. · Class II
NeuroEDUCATOR — CONTROL BIONICS INCORPORATED · Class II
TeleMyo — Noraxon USA, Inc. · Class II
ONDAMED — ONDAMED INC. · Class II
MYOLAB II — MOTION CONTROL, INC. · Class II
Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
nfant® SSB Sensor — NFANT LABS Inc · Class II

Cleared under the same submission

K990356 also covers:

Bagnoli Load Cell Adapter — DELSYS, INC.
Bagnoli-16 EMG System — DELSYS, INC.
Bagnoli-8 EMG System — DELSYS, INC.
dEMG Sensor — DELSYS, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Delsys, Inc.

Sources (1)

FDA UDI 7fc1faa2-dbd8-4fef-8ea7-1198807608b4 34 fields · synced May 30, 2026