AccessGUDID - DEVICE: PainShield 3.0 Driver (07290103422028)

GUDID

Device Identifier (DI) Information

Brand Name: PainShield 3.0 Driver
Version or Model: 3.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-800-0002
Company Name: NANOVIBRONIX INC.

Primary DI Number: 07290103422028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080326793 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17908	Physical therapy ultrasound/neuromuscular stimulation system	An assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFW	Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 07a6151a-2a32-4cfe-8edd-4c5f62f3fa0f
Public Version Date: August 11, 2023
Public Version Number: 2
DI Record Publish Date: July 16, 2023