FDA.report

TGCT & Me

Primary DI
08600157703018
Brand
TGCT & Me
Company
REMEPY HEALTH LTD
Model
1.6.6
Device description
Digital therapeutic support application for individuals living with Tenosynovial Giant Cell Tumor (TGCT).
Published
2026-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KQXGoniometer, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08600157703018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08600157703018086001577030188600157703018

GMDN Terms

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.

Regulatory Flags

DUNS number
625992688
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04260242060316DIERS free²moveDIERS International GmbHKQX2026-03-09
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
09413000113839Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2024-07-12
00855170007409Lafayette Range of Motion InclinometerLAFAYETTE INSTRUMENT COMPANY, INC.KQX2024-02-09
00855170007416ROMI Dual Inclinometer SystemLAFAYETTE INSTRUMENT COMPANY, INC.KQX2024-02-09
03770011995462KForce SensKINVENT BIOMECANIQUEKQX2024-01-03
B758000VMPLU0ViMove+DORSAVI LTDKQX2023-08-30
05694230564019NeckCare SystemNeckCare Holding ehfKQX2023-08-09
00816271020742myoRESEARCH3 (MR3)Noraxon U.S.A., Inc.KQX2023-06-07
04260242060019DIERS formetricDIERS International GmbHKQX2023-06-02
04260242060064DIERS leg axisDIERS International GmbHKQX2023-06-02
04260242060101DIERS staticoDIERS International GmbHKQX2023-06-02
04260242060125DIERS leg axis lateralDIERS International GmbHKQX2023-06-02
04260242060163DIERS leg axisDIERS International GmbHKQX2023-06-02
04260242060170DIERS leg axis lateralDIERS International GmbHKQX2023-06-02
04260242060194DIERS posturaDIERS International GmbHKQX2023-06-02
00850015699115CanarE StrapCanary Medical USA LLCKQX2023-05-17
00850015699122Canary Clinic CartCanary Medical USA LLCKQX2023-05-17
00850015699139CanarE Charging CradleCanary Medical USA LLCKQX2023-05-17
G333KQX001myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & OutcomesFUTURE HEALTH WORKS LTDKQX2023-02-17
55060808320151MotionSense Application Version 1.4ENMOVI LTDKQX2023-01-27
55060808320168MotionSense Application Version 1.5ENMOVI LTDKQX2023-01-27
55060808320120OrthoLogIQ PT Version 1.0ENMOVI LTDKQX2023-01-27
00860007286506KinetigramBioniksKQX2022-12-29
15060808320092MotionSense Digital Goniometer ENMOVI LTDKQX2022-07-15