Help-Mate

FDA 510(k) K813249 · G & W Applied Science Laboratories

Substantially Equivalent

510(k) numberK813249

Submission

Device name
Help-Mate
Applicant
G & W Applied Science Laboratories
Mchenry, IL, US
Received
November 18, 1981
Decision date
December 3, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ESD – Hearing Aid, Air-Conduction, Prescription
Device class
Class I (low risk)
Regulation
21 CFR 874.3300
Specialty
Ear, Nose, Throat

An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.

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K130790LYRIC2ESD · Traditional Phonak, LLC06/27/2013SE
K081136Lyric Hearing AidESD · Traditional Insound Medical, Inc.05/08/2008SE
K021867Insound XT Series Hearing AidESD · Traditional Insound Medical, Inc.11/19/2002SE
K003558Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional Siemens Hearing Instruments, Inc.04/24/2001SE
K984518Sonic Innovations Completely-In-The-Canal DSP Hearing Aid with Soft ShellESD · Traditional Sonic Innovations, Inc.03/12/1999SE
K974751Tranquil Tri-Oe, Tranquil Tri-Coe, Tranquil Tri-CicESD · Traditional General Hearing Instruments, Inc.03/06/1998SE
K974242Argosy Programmable OnqueESD · Traditional Argosy Electronics01/20/1998SE
K973880Sonix Hearing Aid Fitting and Programming SystemESD · Traditional Sonix Technologies, Inc.01/12/1998SE
K974211Opus 2 - Full Concha Series - IteESD · Traditional Bernafon-Maico, Inc.12/15/1997SE

More from Bernafon-Maico, Inc.

510(k)DeviceDecision
K780805S/D 600 Sphygmomanometer and PulsemeterDXN · Traditional 06/06/1978SE
K7806774600 RecorderDSF · Traditional 05/17/1978SE
K780566Health Seat SystemDXN · Traditional 04/21/1978SE

Questions and answers

When was Help-Mate cleared by the FDA?

Help-Mate (K813249) received a 510(k) decision of Substantially Equivalent on December 3, 1981, 15 days after the submission was received.

What is the product code of K813249?

The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.