Product code ISH— Physical Medicine

FDA has cleared 4 devices under product code ISH between 1979 and 2005, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20051 clearance
• 19822 clearances
• 19791 clearance

• Orthopedic Systems, Inc.1 clearance
• Noble Fiber Technologies, Inc.1 clearance
• Mauch Laboratories, Inc.1 clearance
• Kiswood Manufacturing, Inc.1 clearance

• K051256 — SILVERSEAL ORTHOTIC COMPONENT WITH X-STATICNoble Fiber Technologies, Inc.·2005-07-21
• K823396 — FREE FLEX HEEL HEIGHT ADJUSTOROrthopedic Systems, Inc.·1982-11-29
• K820505 — ANKLE/FOOT EXTERNALMauch Laboratories, Inc.·1982-03-08
• K791331 — THE TUCKER-SACH FOOT AND TUCKER-SYME FTKiswood Manufacturing, Inc.·1979-08-03