Company ยท US
Selectivemed Components, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2013. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 7, 2013 | K120922 | GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT Selectivemed Components, Inc. | IPF |
| Jun 26, 2009 | K083756 | GUARDIAN 150 ELECTRODE Selectivemed Components, Inc. | GXY |
| May 20, 2003 | K031053 | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 Selectivemed Components, Inc. | EGJ |
| May 3, 2002 | K020476 | MEDION 6000 Selectivemed Components, Inc. | EGJ |
| Mar 3, 2000 | K993081 | IO-DRIVE Selectivemed Components, Inc. | EGJ |
| Dec 22, 1995 | K946230 | ENDURA REUSABLE TENS AND NMES ELECTRODES Selectivemed Components, Inc. | GZJ |
| Jan 30, 1995 | K945676 | GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES Selectivemed Components, Inc. | GZJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2005 | Selectivemed Components Inc Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, Terminated |
EGJ | K031053 |