Levo

FDA UDI

Class II (US FDA UDI)

by Levo Medical Corporation

Identity

Trade Name: Levo FDA UDI
Generic Name: Tinnitus masking application software FDA UDI
Model / Reference: Patient FDA UDI

Identifiers

Catalog Number: 60452 FDA UDI
Primary DI / UDI-DI: G172604520 FDA UDI
510(k) Number: K140845 FDA UDI
FDA Product Code: KLW FDA UDI
GMDN Term: Tinnitus masking application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tinnitus masking application software

Levo by Levo Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tinnitus masking application software.

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AUDIBEL — Starkey Laboratories Inc. · Class II
NUEAR — Starkey Laboratories Inc. · Class II
AMPLIFON — Starkey Laboratories Inc. · Class II
AUDIGY — Starkey Laboratories Inc. · Class II
AUDIOSYNC — Starkey Laboratories Inc. · Class II
AUDIBEL — Starkey Laboratories Inc. · Class II

Cleared under the same submission

K140845 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Levo Medical Corporation

Sources (1)

FDA UDI f4fe9d16-6027-4430-9dcc-650dbdbc1911 35 fields · synced May 30, 2026