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eWave Electrode Patch

by Wearlinq, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberP00020 UDI-DI Date14 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Ambulatory recorder conductive patch
Model / Ref / Catalog
eWave Electrode Patch, P0002
Primary DI / UDI-DI
P00020
510(k) Number
FDA Product Code
DSH
GMDN Term
Ambulatory recorder conductive patch
Device Class
Class II
Regulation Number
870.2800
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 87 Millimeter
Width — 62 Millimeter

Related devices

Cleared under the same submission (K214073)

Other devices from Wearlinq, Inc.

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No