FDA.reportPublic FDA data

Provant Therapy System

Primary DI
00868924000007
Brand
Provant Therapy System
Company
Regenesis Biomedical, Inc.
Model
4201
Device description
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 TreatmentApplicator 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.
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868924000007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868924000007008689240000078689240000070868924000007

GMDN Terms#

Term, Definition table
TermDefinition
Deep-tissue electromagnetic stimulation system, home-useAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
480-297-5800chavez@regenesisbio.com

Regulatory Flags#

DUNS number
018207519
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868924000021Provant Infinity42102021-01-21
20868924000018Disposable Applicator CoverPVTC302016-09-16
00868924000038Reprieve by RegenesisA2023-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00851979007435OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007442OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007503OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007510OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007527OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007534OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007558OrthoCor MedicalCaerus Corp.ILX2025-03-10
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00851979007572OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007596OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007619OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007015OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007022OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007039OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007046OrthoCor MedicalCaerus Corp.ILX2025-03-03
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00851979007428OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007466OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007480OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007664OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007671OrthoCor MedicalCaerus Corp.ILX2025-03-03
00081009308007TrueStimHi-Dow International IncorporatedILX2023-09-28
00851329005128RecoveryRxBioElectronics CorporationILX2021-03-03