DEVICE: Reprieve by Regenesis (00868924000038)

Device Identifier (DI) Information

Reprieve by Regenesis
A
In Commercial Distribution

Regenesis Biomedical, Inc.
00868924000038
GS1

1
018207519 *Terms of Use
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.
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K223620 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d6068091-8f0a-4c02-b7ff-285fed187c38
August 31, 2023
1
August 23, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
480-297-5800
Randy.Chavez@regenesisbio.com
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