PainShield

Basic Information

• Brand Name: PainShield
• Primary DI: 07290103421014
• Version / Model: PS-30
• Company Name: NANOVIBRONIX INC.
• Labeler DUNS: 080326793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-28
• Public Version: 3
• Public Version Date: 2022-11-14
• Public Version Status: Update
• Public Device Record Key: 4d0eca5a-9e89-4b9d-afbc-2f7a86be2fdf

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFW	Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat	Physical Medicine	890.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11248	Physical therapy ultrasound system	An assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290103421014	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 40 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 27 Degrees Celsius