FDA.reportPublic FDA data

ECKO

Primary DI
00840379058895
Brand
ECKO
Company
Q Eye Eyewear Corp
Model
ECKO READ01 2.5
Device description
Spectacles Readers
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HOISpectacle, magnifying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840379058895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840379058895008403790588958403790588950840379058895

GMDN Terms#

Term, Definition table
TermDefinition
Magnifying spectaclesA device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
826430894
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193968573751MEMBERS MARKMMLR1 PINK 442026-05-19
00193968573768MEMBERS MARKMMLR1 BLUE 442026-05-19
00193968573775MEMBERS MARKMMLR1 RED 442026-05-19
00840379064919MASTER PIECEMP6020 BLK 542026-05-19
00840379064926MASTER PIECEMP6020 BURG 542026-05-19
00840379064933MASTER PIECEMP6021 CRY 552026-05-19
00840379064940MASTER PIECEMP6021 TOB 552026-05-19
00840379065107MASTER PIECEMP6022 MAUV 472026-05-19
00840379065114MASTER PIECEMP6022 TORT 472026-05-19
00840379065121MASTER PIECEMP6023 BLK 492026-05-19
00840379065138MASTER PIECEMP6023 TORT 492026-05-19
00840379066029MASTER PIECEMP6024 OCEAN 602026-05-19
00840379066036MASTER PIECEMP6024 BLK 602026-05-19
00840379066043MASTER PIECEMP6025 BLK 612026-05-19
00840379066050MASTER PIECEMP6025 GREY 612026-05-19
00840379066357MASTER PIECEMP6027 BLK 522026-05-19
00840379066364MASTER PIECEMP6027 TOB 522026-05-19
00840379066449MASTER PIECEMP6026 OLIVE 482026-05-19
00840379066456MASTER PIECEMP6026 SMOKE 482026-05-19
00840379066951DR. SEUSSDS SUNNY 1 SKY2026-05-19

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Primary DI, Brand, Company table
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00628120773927AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773934AYA OpticalClaudia Alan IncHOI2025-01-18
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