FDA.reportPublic FDA data

InBody

Primary DI
08809209591980
Brand
InBody
Company
InBody Co., Ltd.
Model
InGrip(IB-HGSm)
Device description
This is a Handheld Dynamometer
Published
2025-05-09
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
IKKSystem, Isokinetic Testing And Evaluation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809209591980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809209591980088092095919808809209591980

GMDN Terms#

Term, Definition table
TermDefinition
Hand dynamometer/pinchmeter, electronicAn electrically-powered 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 strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke; it may in addition be designed to be used as part of an interactive rehabilitation system whereby forces applied by the patient translate to movements in a video-game. It includes a force transducer to translate force into electrical impulses for measurement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688003404
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809209592321InBodyInBody2802026-02-28
08809209592253InBodyInBody970S2025-10-03
08809209592260InBodyInBody3802025-10-03
08809209592277InBodyInBody5802025-10-03
08809209590280InBodyInBodyH20B2018-05-17
08809209590969InBodyInBodyM202024-07-23
08809209590938InBodyFRA510(s)2023-06-22
08809209590976InBodyBWAON2023-06-22
08809209591676InBodyInBody3802023-06-22
08809209591683InBodyInBody5802023-06-22
08809209590877InBodyBWA2.02022-07-25
08809209591881InBodyInBody270S2024-07-15
08809209591898InBodyInBody770S2024-07-15
08809209591904InBodyInBody970S2024-07-15
08809209591911InBodyBWA2.0S2024-07-15
08809209590945InBodyIB-LS2023-06-22
08809209591362InBodyLookinBody 1202023-06-22
08809209591379InBodyLookinBody M202023-06-22
08809209591386InBodyLookinBody Web2023-06-22
08809209590563InBodyBP1702022-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975343590010Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590027Lower Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590034Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590041Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590058Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590065Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590072Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590089Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590133Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590140Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590157Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590171Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590188Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590195Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590201Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590218Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590225Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590256Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590287Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590300Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
04041925006339PHS - XSmedica - Medizintechnik GmbHIKK2026-05-13
04041925006346PHS - Smedica - Medizintechnik GmbHIKK2026-05-13
04041925006353PHS - Mmedica - Medizintechnik GmbHIKK2026-05-13
04041925006360PHS - Lmedica - Medizintechnik GmbHIKK2026-05-13
04041925006377PHS - XLmedica - Medizintechnik GmbHIKK2026-05-13
B108660POMUS00R-GAITBTL INDUSTRIES LIMITEDIKK2026-03-19
09120077180250LEXOtyromotion GmbHIKK2026-03-12
06979351820015Upper Limb Rehabilitation Training SystemShanghai ZDROID Medical Technology Co.,Ltd.IKK2025-12-23
05061081950009LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03
05061081950184LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03