FDA.reportPublic FDA data

Lafayette Extendable Goniometer

Primary DI
00855170007027
Brand
Lafayette Extendable Goniometer
Company
LAFAYETTE INSTRUMENT COMPANY, INC.
Model
01135
Catalog number
01135
Device description
The Lafayette Extendable Goniometer is an angle measurement device used for accurate, versatile, reliable and objective assessment of range of motion. The Extendable Goniometer features a dual scale, 1° increments, extendable and retractable arms, magnified reading window, as well as a compact, lightweight, and portable design. Its arms can extend to 28.00 inches to measure large joints and retract to 8.0 inches to measure all but the smallest joints. Unlike standard goniometers that require the examiner to estimate alignment, the length of the extendable arms allows it to lie over anatomical bony landmarks. The dual scale of 0-180° and 180-0° is magnified four times, improving the accuracy of the reading, thus, reducing the chance for error. Its lightweight ABS plastic construction will ensure continued and long lasting use.
Published
2021-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQWGoniometer, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQWGoniometer, NonpoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855170007027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855170007027008551700070278551700070270855170007027

GMDN Terms#

Term, Definition table
TermDefinition
Manual goniometerA non-powered, manually-operated measuring device, graduated in degrees (e.g., from 0 to 360 degrees), designed to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. It is typically used by rheumatologists, physiotherapists, orthopaedists and general practitioners to evaluate joint movement (e.g., ankle, finger, knee, shoulder or spine) before and after a medical/surgical intervention. It may be made of plastic or stainless steel and is available in various designs (e.g., protractor-like with pivoting arms, dial-like with twin rotating dials). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature40 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
765-423-1505bbrown@lafayetteinstrument.com

Regulatory Flags#

DUNS number
005080650
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855170007447Pneumograph - Non-Metallic 98in. Tubing76513NM98C76513NM98C2025-08-14
00855170007423DualGrip Digital Grip Dynamometer5030DG5030DG2024-09-11
00855170007409Lafayette Range of Motion InclinometerACU100ACU1002024-02-09
00855170007416ROMI Dual Inclinometer SystemACU100-DUALACU100-DUAL2024-02-09
0085517000738670cm Long Arm Anthropometer01290A01290A2023-06-13
0085517000739330cm Short Arm Anthropometer01291A01291A2023-06-13
00855170007140PNEUMO NONMETALIC 10' LATEX FREE76513NM10A76513NM10A2023-06-12
00855170007157PED NONMETAL PNEUMO 10' LATEX FREE76513NM10P76513NM10P2023-06-12
00855170007164NONMETAL PNEUMO 12' LUER LATEX FREE76513NM12M 76513NM12M 2023-06-12
00855170007195"PNEUMO NONMETALIC 89"" LATEX FREE"76513NM89A 76513NM89A 2023-06-12
00855170007201"PED NONMETAL PNEUMO 89"" LATEX FREE"76513NM89P 76513NM89P 2023-06-12
00855170007034Large Bone Caliper01293012932021-08-31
00855170007041Small Bone Caliper01294012942021-08-31
00855170007232Chest Depth Caliper01140 01140 2021-08-31
00855170007256Abdominal Caliper01296012962021-08-31
00855170007379Lafayette Hand-Held Dynamometer01165A01165A2022-04-28
00855170007003Lafayette Hand-Held Dynamometer01165011652021-08-31
00855170007010Lafayette Skinfold Caliper01128011282021-08-31
00855170007119Professional Hand Evaluation Kit5030K15030K12021-08-31
00855170007126Lafayette Professional Grip Dynamometer5030L15030L12021-08-31

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