FDA.reportPublic FDA data

Back-Leg-Chest Dynamometer

Primary DI
08809513720380
Brand
Back-Leg-Chest Dynamometer
Company
Saehan Corporation
Model
SH5007
Catalog number
SH5007
Device description
SAEHAN Back-Leg-Chest 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
08809513720380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809513720380088095137203808809513720380

GMDN Terms#

Term, Definition table
TermDefinition
Back/leg/chest dynamometer, mechanicalA non-powered, analogue instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and leg muscles during flexion. It includes a mechanical force gauge, which may be attached to a handle or strap, to assess a variety of movements (e.g., leg abduction, lifting) and is typically used to test and control a patient's muscle strength as part of a rehabilitation program.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809513720038SAEHAN Hydraulic Hand DynamometerSaehan CorporationHRW2026-05-18
08809513720052SAEHAN Squeeze DynamometerSaehan CorporationHRW2026-05-18
08809513720076Spring Hand 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