- Physicians Office Resource

Actiwatch Spectrum PRO Japan
Actiwatch Spectrum Pro - Actiwatch Spectrum PRO Japan

Device Description

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.

Environmental Conditions

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
15.00

Storage Environment Temperature - Degrees Fahrenheit

140.00
-4.00

Storage Environment Temperature - Degrees Celsius

60.00
-20.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: IKK

Device Name: System, Isokinetic Testing And Evaluation

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: PM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 890.1925

Third Party Flag: N

Medical Specialty: PM

Device Identifiers

Device Id: 00606959042032

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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