FDA.reportPublic FDA data

Interacoustics

Primary DI
05711117219098
Brand
Interacoustics
Company
Interacoustics A/S
Model
TRV
Published
2020-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXVApparatus, Vestibular Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXVApparatus, Vestibular AnalysisUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711117219098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711117219098057111172190985711117219098

GMDN Terms#

Term, Definition table
TermDefinition
Canalith repositioning procedure chair, manualA device intended to be occupied by a patient and manually operated by a healthcare professional to facilitate therapeutic physical manoeuvres of the patient’s head and trunk (accelerations and decelerations in a multiaxial plan) to treat balance disorders [e.g., benign paroxysmal positional vertigo (BPPV), canalithiasis] caused by displaced canaliths (otoconia) in the inner ear of the patient. It consists of a non-electric patient chair, a floor-standing harness, and securing straps; goggles with a video-camera to diagnose involuntary eye movement (nystagmus) in response to the stimulation of the vestibular system may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306308354
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05711117230796Sanibel Supply A/SSanibel EARturtle Universal85372062026-05-14
05711117230802Sanibel Supply A/SSanibel EARturtle Universal Box of 36 kits w/tab e85372092026-05-14
05711117244304Sanibel Supply A/SSanibel EARturtle Universal Box of 36 kits w/snap 86025002026-05-14
05711117244991InteracousticsVisualEyes 5052025-08-14
05711117245004InteracousticsVisualEyes EyeSeeCam vHIT2025-08-14
05711117245028InteracousticsVisualEyes 5252025-08-14
05711117230833Sanibel Supply A/SER10C-0385372382025-08-07
05711117230840Sanibel Supply A/SER10C-0485372392025-08-07
05711117230857Sanibel Supply A/SER10C-0585372402025-08-07
05711117230864Sanibel Supply A/SER10C-0685372412025-08-07
05711117245097Sanibel Supply A/SER10C-0385372382025-08-07
05711117245103Sanibel Supply A/SER10C-0485372392025-08-07
05711117245110Sanibel Supply A/SER10C-0585372402025-08-07
05711117245127Sanibel Supply A/SER10C-0685372412025-08-07
05711117008395Sanibel SupplyEar tip, OAE-4 ER Infant, 4 mm red flanged2022-12-08
05711117226089Sanibel SupplyEar tip infant 4 mm, ANA-4.0, blue2022-12-08
05711117226096Sanibel SupplyEar tip infant 5 mm, ANA-5.0, green2022-12-08
05711117226102Sanibel SupplyEar tip infant 4,5 mm, ANA-4.5, red-brown2022-12-08
05711117226119Sanibel SupplyEar tip 5 mm, AOT-5.0 light blue2022-12-08
05711117226126Sanibel SupplyEar tip 4 mm, AOT-4.0 green2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858458007870Korebalance MobileDiversified Healthcare Development, LLCLXV2026-04-21
00868168000306SwayHEALTHY ROSTER LLCLXV2026-04-13
00199874750514K-D BalanceKing-Devick Test, Inc.LXV2026-03-03
00858458007009Korebalance PremiereDiversified Healthcare Development, LLCLXV2023-07-31