FDA.reportPublic FDA data

Kintinuum™

Primary DI
B493MC0011
Brand
Kintinuum™
Company
MC10, INC.
Model
MC-0011
Device description
MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05, B493MC0009
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
B493MC0011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology ambulatory recorderA battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature15 Percent (%) Relative Humidity30 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8572145630support@mc10inc.com

Regulatory Flags#

DUNS number
829221139
Device count
1
Premarket exempt
true
Kit
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
B493MC0012BioStamp nPoint™MC-00122018-08-31
B493MC0013BioStamp nPoint™MC-00132018-08-31
B493MC0014BioStamp nPoint™MC-00142018-08-31
B493MC0015BioStamp nPoint™MC-00152018-08-31

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07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
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00850064651003DS5Foresite Healthcare, LLCISD2024-05-24
00850064651010DS6Foresite Healthcare, LLCISD2024-05-24
00850064651027MDSForesite Healthcare, LLCISD2024-05-24
00850064651041DS6Foresite Healthcare, LLCISD2024-05-24
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