Regenesis Biomedical Inc 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 o Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
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 o
Brand
Regenesis Biomedical Inc
Lot Codes / Batch Numbers
Serial Numbers: 704, 920, 460, 709, 711, 714, and 727
Products Sold
Serial Numbers: 704, 920, 460, 709, 711, 714, and 727
Regenesis Biomedical Inc is recalling Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is due to In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Written notification dated September 29, 2008 was sent to consignees by overnight mail notifying them of the nonconformance and providing instructions for return of the affected PROVANT Model 4201A units to Regenesis. Receipt of the notification and return shipping of the units will be verified. Contact Regenesis Biomedical Inc. for additional information at 1-480-970-4970.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NC, VA, WY
Page updated: Jan 10, 2026