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U.S. Department of Health and Human Services

Class 2 Device Recall Regenesis Biomedical PROVANT Wound

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  Class 2 Device Recall Regenesis Biomedical PROVANT Wound see related information
Date Initiated by Firm September 29, 2008
Date Posted January 26, 2009
Recall Status1 Terminated 3 on July 08, 2009
Recall Number Z-0887-2009
Recall Event ID 50230
510(K)Number K972093  
Product Classification diathermy, shortwave - Product Code ILX
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 of postoperative pain and edema in superficial soft tissue.
Code Information Serial Numbers: 704, 920, 460, 709, 711, 714, and 727
Recalling Firm/
Manufacturer		 Regenesis Biomedical Inc
1435 N Hayden Rd
Scottsdale AZ 85257-3773
For Additional Information Contact Richard A. Isenberg, MD
480-970-4970
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Finished device change control
Action 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.
Quantity in Commerce 7 units
Distribution WY, VA, and NC
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ILX and Original Applicant = REGENESIS BIOMEDICAL, INC.
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