Provant Infinity

GUDID 00868924000021

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.

Regenesis Biomedical, Inc.

Deep-tissue electromagnetic stimulation system, home-use
Primary Device ID00868924000021
NIH Device Record Key2af93b37-2a81-4e78-9208-4fdb1bf7870e
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvant Infinity
Version Model Number4210
Company DUNS018207519
Company NameRegenesis Biomedical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com
Phone480-297-5800
EmailRandy.Chavez@regenesisbio.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 12 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS100868924000021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-29
Device Publish Date2021-01-21

Devices Manufactured by Regenesis Biomedical, Inc.

00868924000038 - Reprieve by Regenesis2023-08-31 The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wa
00868924000021 - Provant Infinity2021-01-29The 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.
00868924000021 - Provant Infinity2021-01-29 The device includes a Control Unit and Treatment Applicator. The Control Unit is enclosed in a UL-compliant injection-molded cas
20868924000018 - Disposable Applicator Cover2018-03-29 Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological conta
00868924000007 - Provant Therapy System2018-03-29 The device includes a Control Unit and Treatment Applicator. The Control Unit for the Provant Therapy System is housed in a UL-c

Trademark Results [Provant Infinity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROVANT INFINITY
PROVANT INFINITY
88712842 not registered Live/Pending
Regenesis Biomedical, Inc.
2019-12-03
PROVANT INFINITY
PROVANT INFINITY
88712343 not registered Live/Pending
Regenesis Biomedical, Inc.
2019-12-02

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