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 ID: 00868924000007
• NIH Device Record Key: 16fc2a87-49e1-4d47-a9db-682512539a53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provant Therapy System
• Version Model Number: 4201
• Company DUNS: 018207519
• Company Name: Regenesis Biomedical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 480-297-5800
• Email: chavez@regenesisbio.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868924000007 [Primary]

FDA Product Code

• ILX: Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

Devices Manufactured by Regenesis Biomedical, Inc.

• 00868924000038 - Reprieve by Regenesis: 2023-08-31 The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wa
• 00868924000021 - Provant Infinity: 2021-01-29 The device includes a Control Unit and Treatment Applicator. The Control Unit is enclosed in a UL-compliant injection-molded cas
• 20868924000018 - Disposable Applicator Cover: 2018-03-29 Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological conta
• 00868924000007 - Provant Therapy System: 2018-03-29The 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 System: 2018-03-29 The device includes a Control Unit and Treatment Applicator. The Control Unit for the Provant Therapy System is housed in a UL-c