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U.S. Department of Health and Human Services

Class 3 Device Recall TENS Device

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  Class 3 Device Recall TENS Device see related information
Date Initiated by Firm June 29, 2007
Date Posted September 01, 2007
Recall Status1 Terminated 3 on April 04, 2008
Recall Number Z-1210-2007
Recall Event ID 38308
510(K)Number K062641  
Product Classification Stimulator, Nerve, Transcutaneous, For Pain Relief - Product Code GZJ
Product Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Code Information Lot Number AC024; The lot number can be found on the serial number label located in the recess of the case where the batteries are installed. If the serial number has "AC024" in the middle, then that device is being recalled.
Recalling Firm/
Manufacturer		 Avazzia, Inc
13154 Coit Rd Ste 200
Dallas TX 75240-5787
For Additional Information Contact
972-816-7456
Manufacturer Reason
for Recall		 Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
FDA Determined
Cause 2		 Other
Action Firm notified consignees by letter on June 29, 2007 requesting that all affected product be returned to the firm for repair or replacement. The firm further asked for distributors who had shipped affected product to notify receiving patients so they could arrange for repair or replacement.
Quantity in Commerce 75 units
Distribution Nationwide including states of Texas, Pennsylvania, Louisiana, Wyoming, and California
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 = GZJ and Original Applicant = AVAZZIA, INC.
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