FDA.reportPublic FDA data

SAEHAN Hydraulic Hand Dynamometer

Primary DI
08809513720038
Brand
SAEHAN Hydraulic Hand Dynamometer
Company
Saehan Corporation
Model
SH5001
Catalog number
SH5001
Device description
SAEHAN Hydraulic Hand Dynamometer
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
HRWDynamometer, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRWDynamometer, NonpoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809513720038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809513720038088095137200388809513720038

GMDN Terms#

Term, Definition table
TermDefinition
Hand dynamometer/pinchmeter, mechanicalA non-powered, mechanical instrument designed to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. It is used to assess a patient's grip and/or pinch strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke. This device is commonly known as a Vigorimeter. It typically consists of various size squeeze bulbs and an analogue manometer to record the exerted effort. The patient will typically be asked to perform the test a few times so that the physician can obtain a mean value.

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
08809513720045SAEHAN Hydraulic Pinch GaugeSH5005SH50052026-05-18
08809513720052SAEHAN Squeeze DynamometerSH5008SH50082026-05-18
08809513720069SAEHAN Skinfold CaliperSH5020SH50202026-05-18
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
08809513720052SAEHAN Squeeze DynamometerSaehan CorporationHRW2026-05-18
08809513720076Spring Hand DynamometerSaehan CorporationHRW2026-05-18
08809513720380Back-Leg-Chest DynamometerSaehan CorporationHRW2026-05-18
04719846012660CharderCHARDER ELECTRONIC CO., LTD.HRW2026-04-29
04719846017030CharderCHARDER ELECTRONIC CO., LTD.HRW2026-02-11
14719846017037CharderCHARDER ELECTRONIC CO., LTD.HRW2026-02-11
08033390301848General InstrumentLIMACORPORATE SPAHRW2025-06-10
08033390301855General InstrumentLIMACORPORATE SPAHRW2025-06-10
08033390301862General InstrumentLIMACORPORATE SPAHRW2025-06-10
08033390301879General InstrumentLIMACORPORATE SPAHRW2025-06-10
00855170007423DualGrip Digital Grip DynamometerLAFAYETTE INSTRUMENT COMPANY, INC.HRW2024-09-11
07290103039073One Button Response UnitMEDOC LTD.HRW2023-06-20
08033390237734PRIMA TT GlenoidLIMACORPORATE SPAHRW2022-12-03
08033390237741PRIMA TT GlenoidLIMACORPORATE SPAHRW2022-12-03
08033390109499NALIMACORPORATE SPAHRW2022-09-08
08033390196123NALIMACORPORATE SPAHRW2022-09-08
00840216112728JAMARAsp Global, LLCHRW2022-08-09
00840216112735JAMARAsp Global, LLCHRW2022-08-09
00840216112704JAMARAsp Global, LLCHRW2022-04-27
00840216112667JAMARAsp Global, LLCHRW2022-04-04
00840216112650JAMARAsp Global, LLCHRW2022-03-18
00840216112674JAMARAsp Global, LLCHRW2022-03-18
00840216112681JAMARAsp Global, LLCHRW2022-03-18
00840216112698JAMARAsp Global, LLCHRW2022-03-18
00840216112711JAMARAsp Global, LLCHRW2022-03-18
00840216112742JAMARAsp Global, LLCHRW2022-03-18
00840216112759JAMARAsp Global, LLCHRW2022-03-18
00840216112766JAMARAsp Global, LLCHRW2022-03-18
00840216112773JAMARAsp Global, LLCHRW2022-03-18
00855170007119Professional Hand Evaluation KitLAFAYETTE INSTRUMENT COMPANY, INC.HRW2021-08-31