510(k) K062641 ยท GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
| Applicant | Avazzia, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Apr 30, 2007 |
| Received | Sep 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062641
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2007 | Avazzia, Inc Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240. Terminated |
GZJ | None listed |
| Sep 1, 2007 | Avazzia, Inc Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240. Terminated |
GZJ | None listed |
| Sep 1, 2007 | Avazzia, Inc Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240. Terminated |
GZJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.