FDA.reportPublic FDA data

Actiwave

Primary DI
B329AWVM33
Brand
Actiwave
Company
CAMNTECH LIMITED
Model
Motion
Catalog number
08-565
Device description
Ambulatory Accelerometry recorder - triaxial
Published
2016-09-24
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
LELDevice, Sleep Assessment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LELDevice, Sleep AssessmentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100266000ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603Camntech, Ltd.2010-04-29MWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B329AWVM33PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 830-755-8036sales@camntech.com

Regulatory Flags#

DUNS number
399114941
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B329AH420ActiheartAH408-3052016-09-24
B329AWV01E22Actiwave1E08-5142016-09-24
B329AWV02E25Actiwave2E08-5212016-09-24
B329AWV02M25Actiwave2M08-5362016-09-24
B329AWV04E22Actiwave4E08-5572016-09-24
B329AWVC23ActiwaveCardio08-6032016-09-24
B329PDV25PRO-DiaryPDV05-1212019-08-29
B329MW850MotionWatchMW804-1112016-09-24
B329MWR50MotionWatchMW-R04-1212018-11-02
B329PDM25PRO-DiaryPDM05-1112016-09-24
B329AH556ActiheartAH518-5002019-08-29
B329AHBT56ActiheartAH5 BT18-5052019-08-29

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Primary DI, Brand, Company table
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G012BRCA02BioStamp® nPointMedidata Solutions, Inc.LEL2021-04-01
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