SpringTMS

Basic Information

• Brand Name: SpringTMS
• Primary DI: 00816140020101
• Version / Model: DWG-0096
• Catalog Number: DWG-0096
• Company Name: ENEURA, INC.,
• Labeler DUNS: 013665656
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 2f42f969-133f-4466-b44f-d66b7b4c25bd

Device Description

Transcranial Magnetic Stimulator AC Adapter

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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
OKP	Transcranial magnetic stimulator for the treatment of migraine headache	Neurology	882.5808	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62219	Home-use magnetic neural stimulator	A rechargeable battery-powered device intended to be used for the treatment of pain associated with migraine headache (with or without aura) through noninvasive transcranial magnetic stimulation (TMS) of the brain. It is a hand-held unit intended to be placed at the base of the skull at the earliest onset of symptoms of a migraine headache, to reduce or stop the effects of migraine headache, through generation of a single pulse magnetic field. It is typically programmed to deliver treatment in accordance with a specific patient prescription and is intended to be used in the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816140020101	GS1

Customer Contacts

• Phone: [phone] ext. 126
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140094	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity