FDA.reportPublic FDA data

Healing Healthcare Pro

Primary DI
00860002174006
Brand
Healing Healthcare Pro
Company
DB DIAGNOSTIC SYSTEMS, INC.
Model
Revision 2
Device description
Db Diagnostic Systems Healing Healthcare Pro (Revision 2)
Published
2019-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ETYTester, Auditory Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002174006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002174006008600021740068600021740060860002174006

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing aid testerAn electroacoustic device intended to be used for the evaluation of hearing loss (audiometer function), the evaluation of hearing aids while worn to assure optimal amplification (real-ear measurement), and/or for other hearing aid analysis (functions as the hearing aid analyser to check its proper function when this is being fitted to the patient). It typically consists of a test box and a control unit that connect to a computer that runs application software to provide results and graphics (which may be stored in a database). The control unit may also be connected to other manufacturer's test boxes, or run as an audiometer or real-ear-measurement instrument without the test box.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
089135780
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05711117244557InteracousticsInteracoustics A/SETY2026-07-28
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05713315009587Madsen ZodiacNatus Medical Denmark ApSETY2026-06-04
05713315009594Madsen ZodiacNatus Medical Denmark ApSETY2026-06-04
05713315009624Madsen ZodiacNatus Medical Denmark ApSETY2026-06-04
05713315009426Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009433Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009457Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009471Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009488Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009501Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009518Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009525Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009532Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009556Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009570Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009402Madsen ZodiacNatus Medical Denmark ApSETY2026-06-02
08051597160051ResonanceM.R.S. SRLETY2025-09-01
08051597160099ResonanceM.R.S. SRLETY2025-09-01
04260223142994Sentiero Desktop DiagnosticPATH medical GmbHETY2024-05-22
05060488902673Amplivox AMPLIVOX LIMITEDETY2024-01-08
05060488902635Amplivox AMPLIVOX LIMITEDETY2023-12-22
05060488902680Amplivox AMPLIVOX LIMITEDETY2023-12-22
00732094082760Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084580Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084597Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084702Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084719Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084726Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084733Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17