Pretika

Basic Information

• Brand Name: Pretika
• Primary DI: 00813859002749
• Version / Model: HA274
• Catalog Number: HA274
• Company Name: PRETIKA CORPORATION
• Labeler DUNS: 848304379
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 1
• Public Version Date: 2020-05-08
• Public Version Status: New
• Public Device Record Key: 540901de-258a-437e-9992-c3918f6f033a

Device Description

Pretika Thermal Control Foot Massager

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
ISA	Massager, therapeutic, electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34663	Pneumatic massager, home-use	An pneumatically-powered massager designed for home-use only. It typically has a vibrating head or other feature which may be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may be interchangeable with others of different size and shape.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10813859002746	GS1	Box	2	In Commercial Distribution
Primary	00813859002749	GS1
Package	20813859002743	GS1	Master Carton	3	In Commercial Distribution

Customer Contacts

• Phone: [phone] ext. 101
• Email: [email protected]