Provant Therapy System

GUDID 00868924000007

The device includes a Control Unit and Treatment Applicator. The Control Unit for the Provant Therapy System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy. The Provant Therapy System 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 ID00868924000007
NIH Device Record Key16fc2a87-49e1-4d47-a9db-682512539a53
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvant Therapy System
Version Model Number4201
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
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com
Phone480-297-5800
Emailchavez@regenesisbio.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100868924000007 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

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 Infinity2021-01-29 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 System2018-03-29The device includes a Control Unit and Treatment Applicator. The Control Unit for the Provant Therapy System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy. The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue.
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
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