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510(k) Data Aggregation
K Number
K210021Device Name
Axon Therapy
Manufacturer
NeuraLace Medical, Inc.
Date Cleared
2021-06-11
(158 days)
Product Code
QPL, IPF
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
NeuraLace Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and postsurgical pain for patients 18 and older.
Device Description
The Axon Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide chronic nerve pain relief. The subject device is intended to be used in clinics such as pain management clinics and physical therapy clinics. The device consists of Magnetic Stimulation Coil, Liquid Cool Unit, and a Cart. The Axon Therapy includes a thermal shutdown feature which is activated once the inside temperature of the stimulation coil either: (A) reaches 45°C or (B) exceeds 41°C for a total of nine minutes during a 20-minute session.
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