
Burke Neutech, Inc.
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THERMAFLEX, MODEL SD 55 C.P.M.H. is an FDA 510(k)-cleared medical device (K945803) manufactured by Burke Neutech, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 10, 1995. Regulation: 8.

Synthes (Usa)
SKU K100676
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SKU VM-1270020

Cardinal Health
SKU VM-1270026
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SKU VM-1270057