regenesisbio.comReprieve by RegenesisTM
Regenesis Biomedical, Inc.
REGENESIS BIOMEDICAL, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2032108 | 3003070149 | REGENESIS BIOMEDICAL, INC. | 1 | N | 2026-01-01 | 5301 N Pima Rd Ste 150 SCOTTSDALE AZ US 85250 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00868924000007 | Provant Therapy System - 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. | 480-297-5800 | chavez@regenesisbio.com |
| 00868924000021 | Provant Infinity - 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. | 480-297-5800 | Randy.Chavez@regenesisbio.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 53583 | 1013580424 | K223620 | Reprieve by RegenesisTM | IMJ | 2023-05-24 |
| 53583 | 1792002113 | K131979 | PROVANT THERAPY SYSTEM | ILX | 2013-12-13 |
Product Codes Associated With Registrations#
PMN#
PROVANT THERAPY SYSTEM
REGENESIS BIOMEDICAL, INC.
PROVANT SYSTEM, MODEL 4201
REGENESIS BIOMEDICAL, INC.
REGENESIS MODEL 42
REGENESIS BIOMEDICAL, INC.
GUDID#
Provant Infinity - 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.
2021-01-21
Disposable Applicator Cover - Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological contamination. The cover is non-sterile and manufactured of polyethylene terephthalate (polyester) film and contains a Radio Frequency Identification Device (RFID) tag, which guards against reuse of used Disposable Applicator Covers.
2016-09-16
Provant Therapy System - 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.
2016-09-16
Reprieve by Regenesis - The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wave (CW) mode or a pulsed wave (PW) mode at manufacture (not programmable by the user). The Reprieve by Regenesis SWD device includes a base control unit, one or two treatment applicators, and an external power supply. The base control unit and treatment applicator(s) are enclosed in an injection-molded case made of medical grade poly carbonate. The treatment applicator(s) and power supply are attached to the base control unit. When not in use, the control unit acts as its own carrying case with the treatment applicators stored a slot in the Control Unit, the power supply stored in an attached pouch behind the control unit, and the treatment applicator cables stored using an attached cable management loop. The Reprieve by Regenesis SWD device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
2023-08-23