CLEAR BLUE ENGINEERING, INC.

FDA Device Registration & Listing · Lafayette, CO, US · Registration 3004081884

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
3004081884
FEI Number
3004081884
Entity Name
CLEAR BLUE ENGINEERING, INC.
City/State/Country
Lafayette, CO, US
Establishment Address
1650 Coal Creek Dr., Suite E, Lafayette, CO 80026, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Clear Blue Engineering, Inc. (Owner Number: 10081047)
Owner / Operator Contact Address
1650 Coal Creek Dr., Suite E, Lafayette, CO 80026, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2021-03-12
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2021-03-12

Official Correspondent

Daniel Minardi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Clear Blue Engineering, 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
K221200 Xbody Hungary Kft. XBody Go USA, XBody Pro USA 2023-01-31
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004081884. Last updated year: 2026. Please use registration number 3004081884 when referencing this establishment in official correspondence.
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