PERFORMANCE HEALTH

Basic Information

• Brand Name: PERFORMANCE HEALTH
• Primary DI: 00840216115880
• Version / Model: A3591
• Company Name: Asp Global, LLC
• Labeler DUNS: 080361159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-26
• Public Version: 1
• Public Version Date: 2022-09-05
• Public Version Status: New
• Public Device Record Key: c0cf5b6e-a931-4ab3-9f8e-4817ed6ea11c

Device Description

Rolyan Climbing Board and Bar

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
IOD	Components, Exercise	Physical Medicine	890.5350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61508	Core-body mechanical weight exerciser	A fixed mechanical exercise apparatus intended to enable a patient with a lumbar spine injury to perform controlled extension, contraction, and/or twisting movements of the lumbar/thoracic spine back region and the abdomen, for testing and rehabilitation. It typically consists of a metal frame containing a lever or pulley-cable system that may incorporate changeable weights, and a seat with appropriate supports which allows for resistive movement via connected adjustable weights.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840216115880	GS1