FDA.reportPublic FDA data

Dynatronics Ultra

Primary DI
08719992508662
Brand
Dynatronics Ultra
Company
Enraf-Nonius B.V.
Model
1550000
Device description
Treatment table intended to support a patient in the desired position for examination or treatment within the physiotherapy, rehabilitation and adjacent disciplines.
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INQTable, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INQTable, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719992508662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719992508662087199925086628719992508662

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table, line-poweredA mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
414024224
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
08720618311139Sonopuls 49414989412025-02-11
08720618311177Curapuls 67016709312025-09-23
08809308380782Compact-II34422082025-09-23
08719992508174EN-Dynamic Chest Press14559512025-02-11
08719992508181EN-Dynamic Back Trainer14559522025-02-11
08719992508198EN-Dynamic Pull Down14559532025-02-11
08719992508204EN-Dynamic Abdominal Trainer14559542025-02-11
08719992508211EN-Dynamic Leg Extension14559552025-02-11
08719992508228EN-Dynamic Rowing14559562025-02-11
08719992508235EN-Dynamic Shoulder Press14559572025-02-11
08719992508242EN-Dynamic Adduction14559582025-02-11
08719992508259EN-Dynamic Abduction14559592025-02-11
08719992508266EN-Dynamic Fly14559602025-02-11
08719992508273EN-Dynamic Total Hip14559612025-02-11
08719992508280EN-Dynamic Seated Leg Curl14559622025-02-11
08719992508297EN-Dynamic Seated Leg Press14559632025-02-11
08719992508303EN-Dynamic Triceps Dips14559642025-02-11
08719992508310EN-Dynamic Squat14559652025-02-11
08719992508327EN-Dynamic Rotator14559662025-02-11
08720618311108Sonopuls 19016319512025-02-11

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Primary DI, Brand, Company table
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