DEVICE: Actigraph (00853048008008)

Device Identifier (DI) Information

Actigraph
wGT3X-BT
In Commercial Distribution

ACTIGRAPH L.L.C.
00853048008008
GS1

1
144830952 *Terms of Use
The wGT3X-BT is a body worn device that measures and records physical movement associated with daily activity and sleep. The wGT3X-BT is intended for use in applications where quantifiable measurement and storage of physical movement is desired.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36252 Kinesiology ambulatory recorder
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ISD Exerciser, Measuring
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K080545 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between -10 and 45 Degrees Celsius
Storage Environment Temperature: between -10 and 45 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5d63ffd7-a71b-49b0-bc57-ee443362f8e5
March 05, 2020
4
December 28, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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