PainShield MD Kit 10-100-0001

GUDID 07290103421236

PainShield MD is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions including pain and soft tissue injuries. The low intensity and low frequency ultrasound energy is effective within a diameter of 20 cm and a depth of approximately 3 cm.

NANOVIBRONIX INC.

Physical therapy ultrasound system
Primary Device ID07290103421236
NIH Device Record Key20b1fef6-1ddd-487a-98a8-d38b300735dc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePainShield MD Kit
Version Model Number3.0
Catalog Number10-100-0001
Company DUNS080326793
Company NameNANOVIBRONIX INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com
Phone(914) 233 3004
Emailinfo@nanovibronix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290103421236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PFWStationary Ultrasonic Diathermy Device 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 Date2020-12-30
Device Publish Date2020-12-22

Devices Manufactured by NANOVIBRONIX INC.

07290103420277 - UroShield 3.0 Driver2023-08-02 The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic wa
07290103422011 - PainShield Patch2023-08-01 PainShield patch is a component of the PainShield MD system.
07290103421144 - PainShield 3.0 Actuator2023-07-24 PainShield actuator is part of the PainShield MD System.
07290103421328 - PainShield Plus Actuator 2023-07-24 PainShield Plus Actuator is part of the PainShield Plus system.
07290103422028 - PainShield 3.0 Driver 2023-07-24 PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area
07290103422035 - PainShield Plus 3.0 Driver 2023-07-24 PainShield MD Plus is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selecte
07290103421014 - PainShield2022-11-14 PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area
07290103421267 - PainShield MD Plus Monnthly kit2022-05-24 The Monthly kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable

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