DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756250184
• Version / Model: 1503-25
• Catalog Number: 1503-25
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-21
• Public Version: 2
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 1c2fd16f-30e6-4b6b-acc8-d0d0c68b63ab

Device Description

THERA-BAND® EXERCISE BAND

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ION	EXERCISER, NON-MEASURING	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34181	Body/limb elastic exerciser	An exercise apparatus intended to primarily strengthen one or several major muscle groups of the body (i.e., in the arms, legs, chest, back, and/or abdomen) through repetitive body motion against elastic resistance. It typically consists of elastic bands, cords, straps, tubes, or cables often with handles/grips and sometimes anchors for attachment to fixtures (e.g., doors). The device typically enables the performance of a wide variety of exercise motions including curls, presses, lunges, flies, and raises; it may also be used to improve body flexibility and mobility or as an aid in physical rehabilitation after an injury (e.g., ankle sprain).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756250184	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]