FDA.reportPublic FDA data

BioStamp nPoint™

Primary DI
B493BRCP01
Brand
BioStamp nPoint™
Company
MC10, INC.
Model
BRCP01
Device description
Mobile application phone
Published
2018-08-31
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
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
IKNElectromyograph, Diagnostic
LELDevice, Sleep Assessment
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
IKNElectromyograph, DiagnosticPhysical Medicine2
LELDevice, Sleep AssessmentNeurology2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173510000BioStamp nPointMc10, Inc.2018-05-08DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B493BRCP01PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology/electromyographic sensor setA collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8572145630support@mc10inc.com

Regulatory Flags#

DUNS number
829221139
Device count
1
Serial number
true
Expiration date on label
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
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
B493MC0015BioStamp nPoint™MC-00152018-08-31

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Primary DI, Brand, Company table
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