PainShield

GUDID 07290103421014

PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area. The user may feel minor warmth at the treatment patch site during the treatment period. PainShield MD should be used under the prescription of a physician or physical therapist. PainShield MD is comprised of two elements: a treatment patch that contains the transducer, which delivers ultrasound waves and a portable battery-operated driver.

NANOVIBRONIX INC.

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• Primary Device ID: 07290103421014
• NIH Device Record Key: 4d0eca5a-9e89-4b9d-afbc-2f7a86be2fdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PainShield
• Version Model Number: PS-30
• Company DUNS: 080326793
• Company Name: NANOVIBRONIX INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com
• Phone: (914) 233 3004
• Email: info@nanovibronix.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290103421014 [Primary]

FDA Product Code

• PFW: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-14
• Device Publish Date: 2019-07-28

Devices Manufactured by NANOVIBRONIX INC.

• 07290103420277 - UroShield 3.0 Driver: 2023-08-02 The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic wa
• 07290103422011 - PainShield Patch: 2023-08-01 PainShield patch is a component of the PainShield MD system.
• 07290103421144 - PainShield 3.0 Actuator: 2023-07-24 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 - PainShield: 2022-11-14PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area. The user may feel minor warmth at the treatment patch site during the treatment period. PainShield MD should be used under the prescription of a physician or physical therapist. PainShield MD is comprised of two elements: a treatment patch that contains the transducer, which delivers ultrasound waves and a portable battery-operated driver.
• 07290103421014 - PainShield: 2022-11-14 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 kit: 2022-05-24 The Monthly kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable