PainShield Plus 3.0 Driver 10-800-0006

GUDID 07290103422035

PainShield MD Plus 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 depth of approximately 3 cm.

NANOVIBRONIX INC.

Physical therapy ultrasound/neuromuscular stimulation system

• Primary Device ID: 07290103422035
• NIH Device Record Key: a906462c-0cc5-4ffa-b98f-a78962b2a2a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PainShield Plus 3.0 Driver
• Version Model Number: 3.0
• Catalog Number: 10-800-0006
• Company DUNS: 080326793
• Company Name: NANOVIBRONIX INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• 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 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290103422035 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-16

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: 2023-07-24PainShield MD Plus 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 depth of approximately 3 cm.
• 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: 2022-11-14 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