FDA.reportPublic FDA data

Kintinuum™

Primary DI
B493SW0042
Brand
Kintinuum™
Company
MC10, INC.
Model
SW-0042
Device description
Patient application for Android
Published
2019-02-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B493SW0042PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
8572145630support@mc10inc.com

Regulatory Flags#

DUNS number
829221139
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B493BRCA02BioStamp®BRCA022018-08-31
B493BRCA05BioStamp®BRCA052018-08-31
B493BRCD01BioStamp nPoint™BRCD012018-08-31
B493BRCD02BioStamp®BRCD022018-08-31
B493BRCP01BioStamp nPoint™BRCP012018-08-31
B493BRCP02BioStamp nPoint™BRCP022018-08-31
B493BRCP03BioStamp®BRCP032018-08-31
B493BRCS02BioStamp®BRCS022018-08-31
B493BRCT01BioStamp nPoint™BRCT012018-08-31
B493BSPS01BioStamp®BSPS012018-08-31
B493MC0003BioStamp nPoint™MC-00032018-08-31
B493MC0004BioStamp nPoint™MC-00042018-08-31
B493MC0005BioStamp nPoint™MC-00052018-08-31
B493MC0006BioStamp nPoint™MC-00062018-08-31
B493MC0007BioStamp nPoint™MC-00072018-08-31
B493MC0008BioStamp nPoint™MC-00082018-08-31
B493MC0011Kintinuum™MC-00112019-02-01
B493MC0012BioStamp nPoint™MC-00122018-08-31
B493MC0013BioStamp nPoint™MC-00132018-08-31
B493MC0014BioStamp nPoint™MC-00142018-08-31

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Primary DI, Brand, Company table
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07290016986204XRBehaviorXR HEALTH IL LTDISD2026-05-04
00199874272399SeniorLife.AISENIORLIFE TECHNOLOGIES INC.ISD2026-03-11
00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
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07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
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00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.ISD2025-07-18
00616784050218Pedal Exerciser, Folding, Digital, Hands/FeetDynarex CorporationISD2025-05-29
00850064651102DS6Foresite Healthcare, LLCISD2025-02-07
G741WHREHABV10Waya RehabWELLOVATE, LLCISD2025-02-03
00860010613320StrideLink MercuryStrideLink Inc.ISD2024-12-16
G186EXERSCAN20Exer ScanExer Labs, Inc.ISD2024-09-03
00850067173007Opal V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173014Docking Station V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173021Access Point V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173038Opal DataHub V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850064651003DS5Foresite Healthcare, LLCISD2024-05-24
00850064651010DS6Foresite Healthcare, LLCISD2024-05-24
00850064651027MDSForesite Healthcare, LLCISD2024-05-24
00850064651041DS6Foresite Healthcare, LLCISD2024-05-24
00850064651058DS6Foresite Healthcare, LLCISD2024-05-24