Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Skylark Device with 20 510(k) clearances. The most recent is a 510(k) clearance dated Oct 27, 1999: ST-302 INFRAREX.
| Date | Record | Source |
|---|---|---|
| Oct 27, 1999 | ST-302 INFRAREXK990233 · ILY | 510(k) clearances |
| Jul 29, 1999 | SD-100 SKYEAR THERMOMETERK984506 · FLL | 510(k) clearances |
| Dec 11, 1998 | SD-956 ULTRASOUND THERAPYK981449 · IMI | 510(k) clearances |
| Dec 9, 1998 | BATCH #6060 CONDUCTIVE GELK983964 · GYB | 510(k) clearances |
| Aug 14, 1998 | GB-1002 TENS WITH MASSAGEK964437 · GZJ | 510(k) clearances |
| Mar 6, 1998 | IF-727 INTERFERENTIAL STIMULATORK974585 · LIH | 510(k) clearances |
| Oct 9, 1997 | SD-970EMS ELECTRICAL MUSCULAR STIMULATORK964434 · IPF | 510(k) clearances |
| Feb 13, 1997 | SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)K963729 · GZJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
