Fit Relief

Basic Information

• Brand Name: Fit Relief
• Primary DI: 00850018806800
• Version / Model: 6404
• Company Name: Heatinaclick LLC
• Labeler DUNS: 043038693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-31
• Public Version: 1
• Public Version Date: 2025-02-10
• Public Version Status: New
• Public Device Record Key: 7af9837e-cc52-47d4-869a-ac5553196613

Device Description

Fit Relief Device

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: Yes
• 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
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	890.5850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61168	Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation system	A battery-powered, portable, electronic device designed to apply transcutaneous electrical stimulation to treat: 1) stress and stress-related disorders, including but not limited to anxiety, depression, and insomnia; and 2) neuromuscular symptoms (e.g., pain) and disorders typically as a form of physical therapy. It consists of a pulse generator (EPG) with separate channels for connection of a dedicated electrode/probe for each application. The device may be used in the home or in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850018806800	GS1

Premarket Submissions

Submission Number	Supplement Number
K191938	000