DEVICE: Reprieve by Regenesis (00868924000038)
Device Identifier (DI) Information
Reprieve by Regenesis
A
In Commercial Distribution
Regenesis Biomedical, Inc.
A
In Commercial Distribution
Regenesis Biomedical, Inc.
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.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
34668 | Short-wave diathermy treatment system, home-use |
An assembly of devices designed to be operated by a patient in the home to provide therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency bands of 13 megahertz (MHz) to 27.12 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. This system is typically used to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K223620 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 5 and 40 Degrees Celsius |
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar |
Storage Environment Temperature: between -25 and 70 Degrees Celsius |
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d6068091-8f0a-4c02-b7ff-285fed187c38
August 31, 2023
1
August 23, 2023
August 31, 2023
1
August 23, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
480-297-5800
Randy.Chavez@regenesisbio.com
Randy.Chavez@regenesisbio.com