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 15, 2026, FDA's public records list Burke Neutech with 7 510(k) clearances. The most recent is a 510(k) clearance dated Apr 10, 1996: SPORTS CONTRAST THERAPY SYSTEM ST 7000.
| Apr 10, 1996 | SPORTS CONTRAST THERAPY SYSTEM ST 7000K955326 · ILO | 510(k) clearances |
| Oct 19, 1995 | EPILATORK952117 · KCX | 510(k) clearances |
| Jun 7, 1995 | CONTRAST 7000 THERAPY SYSTEMK943497 · ILO | 510(k) clearances |
| May 11, 1995 | THERMAFLEX, MODEL SD 55 C.P.M.H.K945803 · JFA | 510(k) clearances |
| Aug 3, 1994 | NEURO-AIDEK942926 · GWY | 510(k) clearances |
| May 27, 1994 | TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEMK940160 · ILO | 510(k) clearances |
| May 26, 1993 | LSI6000 THERMAL THERAPY SYSTEMK926151 · ILO | 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
