FDA.reportPublic FDA data

Kinetigram

Primary DI
00860007286513
Brand
Kinetigram
Company
Bioniks
Model
v3
Catalog number
200-00201-DO-01
Device description
Kinetigram is a cloud-based software platform that provides upper mobility assessment. This version supports Microsoft Kinect and Orbbec 3D Cameras.
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00860007286513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007286513008600072865138600072865130860007286513

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing and/or enable viewing of patient performance data.

Contacts#

Phone, Email table
PhoneEmail
(510)747-1947help@bioniks.net

Regulatory Flags#

DUNS number
078436734
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007286506Kinetigramv2200-00201-DO-012022-12-29

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
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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