FDA.reportPublic FDA data

EN-Dynamic Rowing

Primary DI
08719992508228
Brand
EN-Dynamic Rowing
Company
Enraf-Nonius B.V.
Model
1455956
Device description
Powered Exercise Equipment
Published
2025-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719992508228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719992508228087199925082288719992508228

GMDN Terms#

Term, Definition table
TermDefinition
Back row exerciserA mechanical exercise apparatus primarily intended to strengthen the muscles of the back through a repetitive rowing motion (as in rowing a boat with oars) performed with the arms against the force of a weight. It typically consists of a metal frame containing a lever or pulley-cable system that incorporates changeable weights and bars and/or handles/hand stirrups for the user to grip and pull; it may include a bench for the user to exercise while sitting or inclined. The device may also be used to improve back flexibility, mobility, and to strengthen other upper body muscles (e.g., biceps, triceps).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 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
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
08720618311153Endolaser 12016339312025-02-11

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