ROMI Dual Inclinometer System ACU100-DUAL

GUDID 00855170007416

Pair of Lafayette Range of Motion Inclinometers designed for quick wireless connection when taking dual inclinometer measurements. The Lafayette Range of Motion Inclinometer 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.

LAFAYETTE INSTRUMENT COMPANY, INC.

Electronic goniometer/kinesiology sensor
Primary Device ID00855170007416
NIH Device Record Key15f98a0f-6260-4e85-9b06-f82f67f3cf3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameROMI Dual Inclinometer System
Version Model NumberACU100-DUAL
Catalog NumberACU100-DUAL
Company DUNS005080650
Company NameLAFAYETTE INSTRUMENT COMPANY, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone765-423-1505
Emailbbrown@lafayetteinstrument.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100855170007416 [Primary]

FDA Product Code

KQXGoniometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-19
Device Publish Date2024-02-09

Devices Manufactured by LAFAYETTE INSTRUMENT COMPANY, INC.

00855170007423 - DualGrip Digital Grip Dynamometer2024-09-19 The DualGrip Digital Grip Dynamometer is grip strength measuring instrument. It is designed for routine assessment of the grip
00855170007409 - Lafayette Range of Motion Inclinometer2024-02-19 The Lafayette Range of Motion Inclinometer is a wireless digital goniometer/inclinometer that is capable of taking measurements
00855170007416 - ROMI Dual Inclinometer System2024-02-19Pair of Lafayette Range of Motion Inclinometers designed for quick wireless connection when taking dual inclinometer measurements. The Lafayette Range of Motion Inclinometer 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.
00855170007416 - ROMI Dual Inclinometer System2024-02-19 Pair of Lafayette Range of Motion Inclinometers designed for quick wireless connection when taking dual inclinometer measurement
00855170007386 - 70cm Long Arm Anthropometer2023-06-21 The 70cm Long Arm Anthropometer accurately measures distance in cm. It features a fixed arm and a measurement arm that slides a
00855170007393 - 30cm Short Arm Anthropometer2023-06-21 The 30cm Short Arm Anthropometer accurately measures distance in cm. It features a fixed arm and a measurement arm that slides
00855170007140 - PNEUMO NONMETALIC 10' LATEX FREE2023-06-20 The Non-Metallic Pneumos consist of two plastic end pieces connected by a rubber convoluted tube. The pieces are also connected
00855170007157 - PED NONMETAL PNEUMO 10' LATEX FREE2023-06-20 The Non-Metallic Pneumos consist of two plastic end pieces connected by a rubber convoluted tube. The pieces are also connected
00855170007164 - NONMETAL PNEUMO 12' LUER LATEX FREE2023-06-20 The Non-Metallic Pneumos consist of two plastic end pieces connected by a rubber convoluted tube. The pieces are also connected
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.