EN-Dynamic Rowing

Basic Information

• Brand Name: EN-Dynamic Rowing
• Primary DI: 08719992508228
• Version / Model: 1455956
• Company Name: Enraf-Nonius B.V.
• Labeler DUNS: 414024224
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-11
• Public Version: 1
• Public Version Date: 2025-02-19
• Public Version Status: New
• Public Device Record Key: 5d3c696b-ce5e-4eca-abb8-b1f917a5d83f

Device Description

Powered Exercise Equipment

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BXB	Exerciser, Powered	Physical Medicine	890.5380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35639	Back row exerciser	A 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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719992508228	GS1

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius