WAVi Style Ear Clips

Basic Information

• Brand Name: WAVi Style Ear Clips
• Primary DI: B592WH801
• Version / Model: WH801
• Company Name: WAVI CO.
• Labeler DUNS: 007785282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-25
• Public Version: 1
• Public Version Date: 2026-04-02
• Public Version Status: New
• Public Device Record Key: 70d82450-9adf-4098-87c7-3e65baf58b8f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61020	Analytical non-scalp cutaneous electrode	An electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B592WH801	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K162460	000