FDA.reportPublic FDA data

AccuAngle

Primary DI
00860002828701
Brand
AccuAngle
Company
Rom Technologies, Inc
Model
28000
Catalog number
28000
Device description
Battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint
Published
2020-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002828701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002828701008600028287018600028287010860002828701

GMDN Terms#

Term, Definition table
TermDefinition
Electronic goniometer/kinesiology sensorA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-457-6430info@ROMTech.com

Regulatory Flags#

DUNS number
117410715
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
00860002828718PortableConnect10100101002020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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