Bio Protech

Basic Information

• Brand Name: Bio Protech
• Primary DI: 00817120020043
• Version / Model: MaxIF 1k
• Company Name: BIO PROTECH USA, INC.
• Labeler DUNS: 789127011
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 54626088-7826-458e-a8af-446d91ab00a3

Device Description

MaxIF 1k Unit- Interferential Analog Unit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIH	Interferential Current Therapy	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36737	Interferential electrical stimulation system	An electrically-powered device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies (e.g., 4000 and 4100 Hz) that cross-over/interfere, producing a beating frequency (i.e., difference between the frequencies of both stimuli) at the treatment point. It typically consists of an external pulse generator and a set of electrodes placed in position to produce the interference at the desired point. The system is used mainly to relieve/manage intractable pain; some include additional electrodes to provide other types of electrical stimuli or suction for therapeutic massage.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817120020067	GS1	Master Case	4	In Commercial Distribution
Package	00817120020050	GS1	Inner Box	5	In Commercial Distribution
Primary	00817120020043	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100246	000