AccessGUDID - DEVICE: Provant Infinity (00868924000021)

GUDID

Device Identifier (DI) Information

Brand Name: Provant Infinity
Version or Model: 4210
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Regenesis Biomedical, Inc.

Primary DI Number: 00868924000021
Issuing Agency: GS1
Commercial Distribution End Date: April 02, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 018207519 *Terms of Use

Device Description: The device includes a Control Unit and Treatment Applicator. The Control Unit is enclosed in a UL-compliant injection-molded case made of medical grade polycarbonate. The device also includes a Treatment Applicator and an external power supply that are attached to the Control Unit. When not in use, the device is stored inside the carrying case. The device may be removed from the carrying case prior to administration of therapy. Provant Infinity is indicated for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue.

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?
58761	Deep-tissue electromagnetic stimulation system, home-use	An assembly of devices designed to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat. It includes an electrically-powered control unit, application pads/flat coils intended to emit EM radiation to the treatment site (e.g., joint), and carrying case for portability. It is not intended to apply an electric current directly to the body. The system is intended to be used in clinical and home settings.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILX	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131979	000

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
Handling Environment Temperature: between 12 and 32 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 20 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2af93b37-2a81-4e78-9208-4fdb1bf7870e
Public Version Date: June 27, 2025
Public Version Number: 2
DI Record Publish Date: January 21, 2021