AxioSonic Physiotherapy

GUDID 00861681000327

A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply.

AXIOSONIC, LLC

Physical therapy ultrasound system
Primary Device ID00861681000327
NIH Device Record Key2fe9097c-57fa-4e48-8991-8c2a6fad7cf9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxioSonic Physiotherapy
Version Model Number64-405-0004
Company DUNS080247643
Company NameAXIOSONIC, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100861681000327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-09
Device Publish Date2018-07-09

Devices Manufactured by AXIOSONIC, LLC

00861681000327 - AxioSonic Physiotherapy2018-08-09A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply.
00861681000327 - AxioSonic Physiotherapy2018-08-09 A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound dev
00861681000303 - JAS Pulse2018-07-06 A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound dev
00861681000310 - JAS Pulse 3MHz2018-07-06 A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound dev

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