Reprieve by Regenesis
Basic Information
- Brand Name
- Reprieve by Regenesis
- Primary DI
- 00868924000038
- Version / Model
- A
- Company Name
- Regenesis Biomedical, Inc.
- Labeler DUNS
- 018207519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-23
- Public Version
- 1
- Public Version Date
- 2023-08-31
- Public Version Status
- New
- Public Device Record Key
- d6068091-8f0a-4c02-b7ff-285fed187c38
Device Description
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | Physical Medicine | 890.5290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868924000038 | GS1 |
Customer Contacts
- Phone
- 480-297-5800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223620 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity