TONE-A-MATIC

Basic Information

• Brand Name: TONE-A-MATIC
• Primary DI: 06278437251140
• Version / Model: Model B: Multifunctional Knee & Elbow Garment Brace
• Company Name: Tone-A-Matic International Inc
• Labeler DUNS: 249661943
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-19
• Public Version: 1
• Public Version Date: 2023-02-27
• Public Version Status: New
• Public Device Record Key: 5baf7565-d92a-421d-a22e-b24d8f41552e

Device Description

Garment Electrodes

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35709	Electrode/transducer strap, reusable	A strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06278437251140	GS1

Premarket Submissions

Submission Number	Supplement Number
K222863	000