Lafayette Range of Motion Inclinometer

Basic Information

• Brand Name: Lafayette Range of Motion Inclinometer
• Primary DI: 00855170007409
• Version / Model: ACU100
• Catalog Number: ACU100
• Company Name: LAFAYETTE INSTRUMENT COMPANY, INC.
• Labeler DUNS: 005080650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-09
• Public Version: 1
• Public Version Date: 2024-02-19
• Public Version Status: New
• Public Device Record Key: 296b88a9-0bd4-4a7d-90ee-19b40a7a8e95

Device Description

The Lafayette Range of Motion Inclinometer is a wireless digital goniometer/inclinometer that is capable of taking measurements in three different planes. It can record maximal range of motion movements in flexion/extension, rotation, or front to back. An easy-to-read LCD screen displays the real-time angle along with up to six previously recorded measurements. Capable of wireless communication with a second unit for dual inclinometer joint measurements.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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	00855170007409	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 95 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 50 – 95 Degrees Fahrenheit