FDA.reportPublic FDA data

WEARLINQ

Matched from indexed company URL: WearLinq, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30213325673021332567WEARLINQ1N2026-01-011803 Research Blvd #600 Rockville MD US 20850

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
K00010eWave 6-Lead EKG - Continuous wearable electrocardiogram (ECG) monitor1-800-785-4354support@wearlinq.com
P00010eWave Electrode Patch - Adhesive Electrode Patch1-800-785-4354support@wearlinq.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3162761342026401K214073eWave MonitorDSH2022-10-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSH12022-10-20

PMN#

GUDID#