FDA.reportPublic FDA data

MotionSense Application Version 1.4

Primary DI
55060808320151
Brand
MotionSense Application Version 1.4
Company
ENMOVI LTD
Model
SW-1.4-MSAPP
Catalog number
SW-1.4-MSAPP
Device description
MotionSense Application Version 1.4
Published
2023-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55060808320151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5506080832015155060808320151

GMDN Terms#

Term, Definition table
TermDefinition
Electronic goniometer/kinesiology sensorA small electronic device designed to be fastened to a body part (e.g., a patient worn goniometer-, accelerometer-, or gyroscope-sensor), or hand-held by a clinician (e.g., goniometer), to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness. Acquired data may be transferred to a computing device/software for recording/display and analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
225424353
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
55060808320168MotionSense Application Version 1.5SW-1.5-MSAPPSW-1.5-MSAPP2023-01-27
55060808320120OrthoLogIQ PT Version 1.0SW-1.0-OIQPTSW-1.0-OIQPT2023-01-27
15060808320092MotionSense Digital Goniometer 007-00066-US007-00066-US2022-07-15
15060808320108MotionSense Adhesive Refill Kit007-00067-US007-00067-US2022-07-15
15060808320115MotionSense Knee Alignment Block007-00068-US007-00068-US2022-07-15
55060808320076MotionSense Application Version 1.3 SW-1.3-MSAPPSW-1.3-MSAPP2022-07-15
15060808320023MotionSense Adhesive Refill KitMotionSense 2.0007-00037-US2021-08-13
15060808320030MotionSense Knee Alignment BlockMotionSense 2.0007-00038-US2021-08-13
55060808320007MotionSense Digital GoniometerMotionSense 2.0007-00036-US2021-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600157703018TGCT & MeREMEPY HEALTH LTDKQX2026-05-24
00816271020698UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020803myoRESEARCHNoraxon U.S.A., Inc.KQX2026-03-30
00816271020865UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020872UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021039UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021046UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021053UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021060UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021077UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021084UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021091UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021107UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021114UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021121UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021138UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021145UltiumNoraxon U.S.A., Inc.KQX2026-03-30
04260242060316DIERS free²moveDIERS International GmbHKQX2026-03-09
00852184003670Motor Point Probe, Synchrony Synapse Biomedical, Inc.KQX2025-10-31
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.KQX2025-10-23
00852184003779Kit, Wireless Charger USA 5WSynapse Biomedical, Inc.KQX2025-10-23
00850004866184ActivForce 2ActivBody, Inc.KQX2025-09-03
05694230564002NeckCare AssessmentsNeckCare Holding ehfKQX2025-05-30
05694230564033NeckCare DeviceNeckCare Holding ehfKQX2025-05-30
09413000126259myDigitalKnee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-03-25
09413000126273myDigitalKnee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-03-25
09413000123395Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-01-15
09413000123418Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-01-15
10853818007504USB C AdapterPRECISION BIOMETRICS INCKQX2024-09-03
00853818007491USB A to C CablePRECISION BIOMETRICS INCKQX2024-09-03