Frida

Basic Information

• Brand Name: Frida
• Primary DI: 00810028771697
• Version / Model: 02501800
• Company Name: Fridababy, LLC
• Labeler DUNS: 783729598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2025-07-02
• Public Version: 1
• Public Version Date: 2025-07-10
• Public Version Status: New
• Public Device Record Key: 9e65c1a1-2b4e-4221-ba53-958c2ee24ad8

Device Description

Anti-Nausea Bands

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
MVV	Device, Acupressure	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58072	Acupressure wristband	A device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea. The device is typically an adjustable strap made of medical grade thermoplastic material that includes a mechanical pressure dial (a notched wheel) that can be manually rotated by the user to increase or decrease the applied acupressure. It is intended to alleviate nausea caused by various conditions including pregnancy (morning sickness), motion sickness (travel sickness), post anaesthesia sickness, and chemotherapy sickness. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810028771697	GS1
Package	10810028771694	GS1	Carton	4	In Commercial Distribution
Unit of Use	00810028777972	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K220289	000