Provant Infinity
GUDID 00868924000021
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.
Regenesis Biomedical, Inc.
Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use Deep-tissue electromagnetic stimulation system, home-use| Primary Device ID | 00868924000021 |
| NIH Device Record Key | 2af93b37-2a81-4e78-9208-4fdb1bf7870e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Provant Infinity |
| Version Model Number | 4210 |
| Company DUNS | 018207519 |
| Company Name | Regenesis Biomedical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com | |
| Phone | 480-297-5800 |
| Randy.Chavez@regenesisbio.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 12 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868924000021 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131979
FDA Product Code
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-29 |
| Device Publish Date | 2021-01-21 |
Devices Manufactured by Regenesis Biomedical, Inc.
| 00868924000038 - Reprieve by Regenesis | 2023-08-31 The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wa |
| 00868924000021 - Provant Infinity | 2021-01-29The 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. |
| 00868924000021 - Provant Infinity | 2021-01-29 The device includes a Control Unit and Treatment Applicator. The Control Unit is enclosed in a UL-compliant injection-molded cas |
| 20868924000018 - Disposable Applicator Cover | 2018-03-29 Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological conta |
| 00868924000007 - Provant Therapy System | 2018-03-29 The device includes a Control Unit and Treatment Applicator. The Control Unit for the Provant Therapy System is housed in a UL-c |
Trademark Results [Provant Infinity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROVANT INFINITY 88712842 not registered Live/Pending |
Regenesis Biomedical, Inc. 2019-12-03 |
 PROVANT INFINITY 88712343 not registered Live/Pending |
Regenesis Biomedical, Inc. 2019-12-02 |
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