Regenesis Biomedical Inc
Scottsdale, AZ, US
REGENESIS BIOMEDICAL, INC. appears in FDA device records in Scottsdale, AZ. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Regenesis Biomedical Inc between 1997 and 2023. The busiest year on record is 1997, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223620 | Reprieve by RegenesisTM | IMJ | Substantially Equivalent | |
| K131979 | PROVANT THERAPY SYSTEM | ILX | Substantially Equivalent | |
| K091791 | PROVANT SYSTEM, MODEL 4201 | ILX | Substantially Equivalent | |
| K972093 | REGENESIS MODEL 42 | ILX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2032108 | 3003070149 | REGENESIS BIOMEDICAL, INC. | 5301 N Pima Rd Ste 150, SCOTTSDALE, AZ 85250 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0887-2009 | Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. | In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. As such, for these few devices, the effectiveness of Provant therapy may be impaired. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain