FDA.reportPublic FDA data

SAEHAN Skinfold Caliper

Primary DI
08809513720069
Brand
SAEHAN Skinfold Caliper
Company
Saehan Corporation
Model
SH5020
Catalog number
SH5020
Device description
SAEHAN Skinfold Caliper
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FTYTape, Measuring, Rulers And Calipers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809513720069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809513720069088095137200698809513720069

GMDN Terms#

Term, Definition table
TermDefinition
Skinfold calliper, manualA hand-held manual instrument designed to assess body fat in subcutaneous adipose tissue by measuring, using mechanical means, the thickness of folds of skin gathered at various areas of the body (typically that on the posterior aspect of the upper arm or on the thighs, back, or over the lower ribs of the chest). It is typically made of metal and/or plastic and is available in various shapes; it includes moveable arms/jaws, typically spring-loaded for even pressure, for application to the skinfolds and has a graduated scale for skinfold-thickness indication. It may include an auxiliary graduated scale to facilitate fine adjustment and increase measurement accuracy (i.e., vernier callipers).

Contacts#

Phone, Email table
PhoneEmail
+82552940381saehancorp@naver.com

Regulatory Flags#

DUNS number
689240554
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809513720038SAEHAN Hydraulic Hand DynamometerSH5001SH50012026-05-18
08809513720045SAEHAN Hydraulic Pinch GaugeSH5005SH50052026-05-18
08809513720052SAEHAN Squeeze DynamometerSH5008SH50082026-05-18
08809513720076Spring Hand DynamometerSH5002SH50022026-05-18
08809513720298SAEHAN Digital Hand Dynamometer(DHD-1)SH1001SH10012026-05-18
08809513720359SAEHAN Mechanical Pinch GaugeSH5005-1SH5005-12026-05-18
08809513720373SAEHAN Digital Hand Dynamometer(DHD-3)SH1003SH10032026-05-18
08809513720380Back-Leg-Chest DynamometerSH5007SH50072026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445928780SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928797SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928803SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928810SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928827SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928834SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928841SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928858SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
00850085914002IMRISeyeIMRIS Imaging, Inc.FTY2026-05-07
G4250010My MedicalMy Medical Store LLCFTY2026-05-04
G4250020My MedicalMy Medical Store LLCFTY2026-05-04
04719846011786CharderCHARDER ELECTRONIC CO., LTD.FTY2026-04-29
00190776418724MillenniumAvalign Technologies, Inc.FTY2026-04-09
00757770413607Bausch + LombBausch & Lomb IncorporatedFTY2026-03-31
00840117349827Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
00842071152956AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
00887868287510Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108027Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108034Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108041Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108058Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108065Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108096Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
08809986680198Magic RulerInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)FTY2025-10-30
09348215165192Tendon RulerSIGNATURE ORTHOPAEDICS PTY LTDFTY2025-10-10
G79151202DMD000G0WishFIXRed Star Contract Manufacturing Inc.FTY2025-10-06
00371347019841Advance Dental ProductsThe Atlanta Dental Supply CompanyFTY2025-10-02
10197344154654MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
04946585251672CROWNJUN Micro ScaleKONO SEISAKUSHO CO.,LTD.FTY2024-11-14
14026704920553KMEDICTELEFLEX INCORPORATEDFTY2024-07-15