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Tranquil II OTE

FDA UDI

Class II (US FDA UDI)

by General Hearing Instrument, Inc.

Identity

Trade Name
Tranquil II OTE FDA UDI
Generic Name
Air-conduction tinnitus masker, out-of-ear FDA UDI
Device Name
The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus FDA UDI
Model / Reference
Tranquil II,OTE,10A,Digital,Brown,Pair FDA UDI
Description
The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus FDA UDI

Identifiers

Primary DI / UDI-DI
00089518000382 FDA UDI
510(k) Number
K061459 FDA UDI
FDA Product Code
KLW FDA UDI
GMDN Term
Air-conduction tinnitus masker, out-of-ear 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Air-conduction tinnitus masker, out-of-ear

Tranquil II OTE by General Hearing Instrument, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction tinnitus masker, out-of-ear.

Cleared under the same submission

K061459 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
General Hearing Instrument, Inc.

Sources (1)

  • FDA UDI 58a01bef-1ecf-482e-9505-325f604c5222 35 fields · synced May 30, 2026