HoMedics

Basic Information

• Brand Name: HoMedics
• Primary DI: 00031262113733
• Version / Model: BM-IS500J
• Company Name: FKA DISTRIBUTING CO., LLC
• Labeler DUNS: 183280973
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-18
• Public Version: 1
• Public Version Date: 2024-07-26
• Public Version Status: New
• Public Device Record Key: 441d3f21-2d42-48f6-9b67-a19cd8637569

Device Description

Compact Inversion back stretcher

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: 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
INW	Table, Mechanical	Physical Medicine	890.3750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46763	Inversion table	A fixed framework with a tilting table platform designed to support the body of a patient and provide traction for the back muscles and spine by allowing the patient manually invert their entire body in a supine position (feet up and head down). The patient locks their feet behind a cross-member or in straps and leans backwards, pivoting the table on a central pivot, to decompress the spine by diminishing the influence of gravity and allowing the muscles and ligaments that encase the spine to relax; it may also help increase the space between the vertebrae. This device can be used in a healthcare facility or in the home to assist patients eliminate/alleviate back pain.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00031262113733	GS1