FDA.reportPublic FDA data

OtoNova Charger

Primary DI
05060396171529
Brand
OtoNova Charger
Company
OTODYNAMICS LIMITED
Model
NOVA-CHG
Device description
Medical Power Supply Unit for OtoNova Wireless Charging Pad
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWOAudiometer
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234095000OtoNova/OtoNova ProOtodynamics2024-06-21EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060396171529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060396171529050603961715295060396171529

GMDN Terms#

Term, Definition table
TermDefinition
Otoacoustic emission system, battery-poweredAn assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-659-7776info@otodynamics.com

Regulatory Flags#

DUNS number
235908050
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060396171130Crib/bassinet device holster for OtoNovaNOVA-CRIB2024-08-20
05060396171512Tablet Computer for OtoNova Pro NOVA-TABLET2024-08-20
05060396171536OtoNova Wireless Charging PadNOVA-CHG-PAD2024-08-20
05060396172243XPD Ear ProbePR-XPD2024-08-20
05060396172359ABR Electrode Cable (SNAP) for OtoNova ProNPRO-SEC2024-08-20
05060396172366ABR Electrode Cable (TAB) for OtoNova ProNPRO-TEC2024-08-20
05060396172809OtoNova Battery Assembly Service KitON-BATT-KIT2024-08-20
05060396173011OtoNova Pro OAE+AABR instrumentOTONOVAPRO2024-08-20
05060396173042OtoNova Pro Main PCB Service KitON2-MAIN2024-08-20
05060396173059OtoNova Pro Charger PCB Service KitON2-CHG-KIT2024-08-20
05060396173080OtoNova Pro Case Service KitON2-CASE-KIT2024-08-20
05060396173103OtoNova Pro Screener TENPRO-SCR-T2024-08-20
05060396173110OtoNova Pro Screener DPNPRO-SCR-D2024-08-20
05060396173127OtoNova Pro Screener AABRNPRO-SCR-A2024-08-20
05060396173134OtoNova Pro Screener DP+TENPRO-SCR-DT2024-08-20
05060396173141OtoNova Pro Screener TE+AABRNPRO-SCR-TA2024-08-20
05060396173158OtoNova Pro Screener DP+AABRNPRO-SCR-DA2024-08-20
05060396173165OtoNova Pro Screener DP+TE+AABRNPRO-SCR-DTA2024-08-20
05060396173172OtoNova Pro Clinical+TE+AABRNPRO-CLN-DTA2024-08-20
05060396173479OtoNova Pro User ManualMANNPRO2024-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713315006890Madsen AccsucreenNatus Medical Denmark ApSGWJ2026-07-08
05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWJ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWJ2026-07-07
057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007511066 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020021027Toy Cabinet (Small)INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021034Bone Vibrator w/Cable and Headband (B71)INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021089DD45-300 Headphones with Pediatric HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021096DD45-300 Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021133OAE Probe OP23INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021218DD450 HF HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021225DD45S (10 Ohms) HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021232DD45S (10 Ohms) Headphones with Pediatric HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021249DD45S (10 Ohms) Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020020280Capella2 OAE Start-Up KitINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021003B81 Bone VibratorINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021010B81 Bone Vibrator CableINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021171Bone Vibrator Cable for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29