WEARLINQ

FDA Device Registration & Listing · Rockville, MD, US · Registration 3021332567

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
3021332567
FEI Number
3021332567
Entity Name
WEARLINQ
City/State/Country
Rockville, MD, US
Establishment Address
1803 Research Blvd, #600, Rockville, MD 20850, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
WearLinq (Owner Number: 10087780)
Owner / Operator Contact Address
1803 Research Blvd, #600, Rockville, MD 20850, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K214073
PMA Number
N/A

All Registered Proprietary Names

eWave

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2023-04-07

Official Correspondent

Sean Daniel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021332567. Last updated year: 2026. Please use registration number 3021332567 when referencing this establishment in official correspondence.
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