The Fischer

Basic Information

• Brand Name: The Fischer
• Primary DI: 04260587510200
• Version / Model: 07-80-000-09
• Company Name: Saalmann medical GmbH & Co. KG
• Labeler DUNS: 313291191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-15
• Public Version: 2
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 972650c9-3e5d-49ab-8f28-a7e09a4a4d87

Device Description

Tap Water Iontophoresis Device for Treatment of Hyperhidrosis (Hands and Feet)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	890.5525	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17421	Hyperhidrosis iontophoresis system	An assembly of electrically-powered devices intended to be used to transport ions in tap water (water from a faucet) and/or a water solution (e.g., glycopyrrolate and aluminium chloride) to the sweat ducts of heavy sweating areas of the body (e.g., hands, underarms, or feet) in patients that suffer from excessive perspiration (hyperhidrosis) to help minimize or stop sweating. Hyperkeratotic plugs develop in the sweat ducts as a result of the currents and hyperhidrosis is controlled.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260587510200	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191436	000