FDA.reportPublic FDA data

TruVue

Primary DI
30603354600677
Brand
TruVue
Company
EHOB INC
Model
REV00
Catalog number
TRU0170A1
Device description
TruVue Air - Single
Published
2025-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30603354600677PackageGS16In Commercial Distribution
10603354600666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3060335460067730603354600677
1060335460066610603354600666

GMDN Terms#

Term, Definition table
TermDefinition
Foot friction/impact protectorA device designed to be worn over/on the foot, often while wearing shoes, to provide a cushion to protect the whole foot or parts of the foot (e.g., toes, metatarsal heads, heel) from friction against surfaces or knocks against objects, to relieve pain during walking, and/or to prevent formation of hard areas and callouses. It is typically made of soft-padded or gel materials in a variety of forms (e.g., strip, pad, elastic band, digital tube), and some types may be inflatable or held in place with bands or straps around the foot. It is not specifically designed to protect a bunion. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
150600252
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603354130439BAMREV00Z0156A12024-09-03
10603354130538BAMREV00Z0164A12024-09-03
10603354600666TruVueREV00TRU0170A12025-03-20
10603354600680TruVueREV00TRU0170B12025-03-20
10603354600703TruVueREV00TRU0170HAA12025-03-20
10603354120669ComfortTopREV00PPCMFTOP2025-01-22
30603354120670ComfortTopREV00PPCMFTOP2025-01-22
10603354201641WAFFLEREV002180WCHA0102024-12-18
10603354201665WAFFLEREV002200WCHA0102024-12-18
10603354201689WAFFLEREV002300WCHA0102024-12-18
10603354201726WAFFLEREV002000WCHA0102024-12-18
10603354300696WAFFLEREV005450CXHA0102024-12-18
30603354201652WAFFLEREV002180WCHA0102024-12-18
30603354201676WAFFLEREV002200WCHA0102024-12-18
30603354201690WAFFLEREV002300WCHA0102024-12-18
10603354201702WAFFLEREV002400WCHA0102024-12-18
30603354201737WAFFLEREV002000WCHA0102024-12-18
30603354300706WAFFLEREV005450CXHA0102024-12-18
10603354130200BAMREV00B0155A12024-09-12
10603354130248BAMREV00B0155C12024-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
00505627930841Repose Flex Large x10 &Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308434Repose Flex Large x1 & Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308458Repose Flex Large x10 &Pump x10Frontier Therapeutics IncFMP2026-06-05
00860010482674AcanthusAcanthus Medical Creations LLCFMP2026-05-27
10603354600666TruVueEHOB INCFMP2025-03-20
10603354300696WAFFLEEHOB INCFMP2024-12-18
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
G096R9292209LineRising Eagle Medical LLCFMP2024-01-30
20845854082536Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
00609271009004DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009011DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271166004DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166011DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166028DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166035DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166042DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166059DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166066DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166073DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166080DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166097DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166103DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166110DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166127DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166134DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08