DELSYS INC.

FDA Device Registration & Listing · Natick, MA, US · Registration 1226013

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1226013
FEI Number
3002539571
Entity Name
DELSYS INC.
City/State/Country
Natick, MA, US
Establishment Address
23 Strathmore Rd, Natick, MA 01760, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Delsys Inc. (Owner Number: 10027850)
Owner / Operator Contact Address
23 Strathmore Rd., Natick, MA 01760, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Trigno Wireless Biofeedback System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HCC Device, Biofeedback Neurology Class 2 882.5050 2008-12-08

Official Correspondent

Gianluca De Luca

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Delsys Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K873418 Bodylog, Inc. BODYLOG STRESS REDUCTION PACKAGE 1987-12-17
K792659 Bio-Feedback Systems, Inc. FEEDBACK EDR SYSTEM MODEL ME-1 1980-01-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226013. Last updated year: 2026. Please use registration number 1226013 when referencing this establishment in official correspondence.
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