AccessGUDID - DEVICE: Megapulse II (00858703006078)

GUDID

Device Identifier (DI) Information

Brand Name: Megapulse II
Version or Model: 1903029
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ACCELERATED CARE PLUS CORP

Primary DI Number: 00858703006078
Issuing Agency: GS1
Commercial Distribution End Date: August 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 828331616 *Terms of Use

Device Description: Shortwave Diathermy for use in applying therapeutic deep heat

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:	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?
11246	Short-wave diathermy treatment system generator	A component of a short-wave therapeutic diathermy system designed to generate electromagnetic (EM) energy in the radio-frequency (RF) bands of 13 megahertz (MHz) to 27.12 MHz applied transcutaneously to provide a deep heat within specific volumes of the body. The energy generated by this device is typically conducted using electrodes placed on the patient's skin across the area to be treated; the energy is passed between the electrode poles to treat pain, muscle spasms, and joint contractures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMJ	Diathermy, Shortwave, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 40b5c620-fa83-453e-9488-1485cbc7773b
Public Version Date: August 22, 2023
Public Version Number: 4
DI Record Publish Date: August 16, 2016