MotionSense Digital Goniometer

Basic Information

• Brand Name: MotionSense Digital Goniometer
• Primary DI: 15060808320092
• Version / Model: 007-00066-US
• Catalog Number: 007-00066-US
• Company Name: ENMOVI LTD
• Labeler DUNS: 225424353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-15
• Public Version: 2
• Public Version Date: 2023-10-17
• Public Version Status: Update
• Public Device Record Key: 4725dc77-3ca6-4bc6-9395-c5a31fc08529

Device Description

MotionSense Digital Goniometer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KQX	Goniometer, Ac-Powered	Orthopedic	888.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33652	Electronic goniometer/kinesiology sensor	A small electronic device designed to be fastened to a body part (e.g., a patient worn goniometer-, accelerometer-, or gyroscope-sensor), or hand-held by a clinician (e.g., goniometer), to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness. Acquired data may be transferred to a computing device/software for recording/display and analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060808320092	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 25 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 75 Percent (%) Relative Humidity