AccessGUDID - DEVICE: PainShield (07290103421014)

GUDID

Device Identifier (DI) Information

Brand Name: PainShield
Version or Model: PS-30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NANOVIBRONIX INC.

Primary DI Number: 07290103421014
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?	Labeling does not contain MRI Safety Information
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:	Yes
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?
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.	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 Humidity: between 40 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d0eca5a-9e89-4b9d-afbc-2f7a86be2fdf
Public Version Date: November 14, 2022
Public Version Number: 3
DI Record Publish Date: July 28, 2019