FDA.reportPublic FDA data

E-LINK R500 ROM Kit (Range of Motion)

Primary DI
05060481690072
Brand
E-LINK R500 ROM Kit (Range of Motion)
Company
BIOMETRICS LIMITED
Model
R500
Device description
Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting.The Biometrics Range of Motion Kit (R500) provides precise electronic tools for:upper and lower extremity range of motion measurements
Published
2018-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISDExerciser, Measuring
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060481690072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060481690072050604816900725060481690072

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
519969810
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060481690454E-LINK Software (Version 16)16xx-xxx-xxxx2018-08-09
05060481691420SX230-1000 EMG SensorSX230-1000bandwidth 20-460 plastic connector2018-08-09
05060481691437SX230-1000 EMG SensorSX230-1000bandwidth 5-480 plastic connector2018-08-09
05060481691444SX230-1000 EMG SensorSX230-1000bandwidth 5-1000 plastic connector2018-08-09
05060481691451SX230-100 EMG SensorSX230-100Gain 100, bandwidth 20-460 plastic connector2018-08-09
05060481691468SX230FW EMG SensorSX230FWbandwidth 20-460 plastic connector2018-08-09
05060481691475SX230-1000 EMG SensorSX230-1000bandwidth 20-460 metal connector2018-08-10
05060481691482SX230-1000 EMG SensorSX230-1000bandwidth 5-480 metal connector2018-08-10
05060481691499SX230-1000 EMG SensorSX230-1000bandwidth 5-1000 metalconnector2018-08-10
05060481691505SX230-100 EMG SensorSX230-100Gain 100, bandwidth 20-460 metal connector2018-08-10
05060481691512SX230FW EMG SensorSX230FWbandwidth 20-460 metal connector2018-08-10
05060481690003E-LINK X4 Interface UnitX4X4 MkIV plastic connectors2018-02-14
05060481690195E-LINK DG1 Wireless DongleDG12018-08-09
05060481690201E-LINK CA1 Battery ChargerCA12018-08-09
05060481690218E-LINK AD1 Wireless AdaptorAD12018-08-09
05060481690492E-LINK X4 Interface UnitX4X4 MkII metal connectors2018-08-09
05060481690607DataLITE DG2 Wireless DongleDG22018-08-09
05060481690614DataLITE CA2 Battery ChargerCA22018-08-09
05060481690621DataLITE AD2 Wireless AdaptorAD22018-08-09
05060481692465E-LINK EX2 Interface Unit for M400EX22018-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065013876061Sword ThriveSWORD HEALTH, S.A.ISD2026-06-02
08717524641085Lode B.V.Lode B.V.ISD2026-06-01
08717524641092Lode B.V.Lode B.V.ISD2026-06-01
07649998859059NUSHUMagnes AGISD2026-05-31
08600157703018TGCT & MeREMEPY HEALTH LTDKQX2026-05-24
07290016986211XRBehaviorXR HEALTH IL LTDISD2026-05-14
07290016986204XRBehaviorXR HEALTH IL LTDISD2026-05-04
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
00199874272399SeniorLife.AISENIORLIFE TECHNOLOGIES INC.ISD2026-03-11
04260242060316DIERS free²moveDIERS International GmbHKQX2026-03-09
00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
00853858006522EmbraceMiniEMPATICA SRLISD2026-02-16
00853858006713EmbraceMiniEMPATICA SRLISD2026-02-16
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26