Reprieve by Regenesis
Reprieve by Regenesis is a prescription shortwave diathermy device that generates deep heating in body tissues for relief of pain and muscle spasms. It consists of a base control unit, one…
Reprieve by Regenesis is a prescription shortwave diathermy device that generates deep heating in body tissues for relief of pain and muscle spasms. It consists of a base control unit, one or two treatment applicators and an external power supply.
The system generates a 27.12 MHz radiofrequency signal and delivers it through treatment applicators connected by fixed coaxial cables. The device is configured for continuous-wave or pulsed-wave operation; the treatment mode is programmed during manufacture rather than selected by the user.
Listed Item
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.
Controls and Storage
An LCD, buttons and an LED light bar provide the interface. When the system is stored, the applicators fit into slots in the base unit, with separate storage for the power supply and cables.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
Record
| Listed by | Regenesis Biomedical, Inc., United States |
|---|---|
| FDA product code | IMJ |
| Device type | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5290 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K223620 |
| Record published | 2023-08-23 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment temperature 5 to 40 °C; Handling environment humidity 15 to 90 % RH; Handling environment atmospheric pressure 700 to 1060 millibar; Storage environment temperature -25 to 70 °C; Storage environment humidity 15 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Chattanooga | DJO, LLC | 10 |
| ThermoPro | Zimmer Medizinsysteme Gmbh | 1 |
| Megapulse III/OmniSWD | Accelerated Care Plus Corp. | 1 |
| Richmar TheraTouch | Drive DeVilbiss Healthcare | 1 |
| Auto*Therm 390 | Mettler Electronics Corp. | 1 |
| Replexa+ Device | Promedtek, Inc. | 1 |
| Megapulse II | Accelerated Care Plus Corp. | 1 |
| Curapuls 670 | Enraf-Nonius B.V. | 1 |
| Replexa+ Treatment Applicator | Promedtek, Inc. | 1 |
| Drum Applicator 3980 | Mettler Electronics Corp. | 1 |
| BTL-703 | Btl Industries, Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223620 | 2023-05-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.