Product code IPY— Physical Medicine

FDA has cleared 11 devices under product code IPY between 1979 and 1983, filed by 8 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.

• 19832 clearances
• 19815 clearances
• 19803 clearances
• 19791 clearance

• Orthomedics3 clearances
• Surgical Appliance Industries, Inc.2 clearances
• Vertebrace, Inc.1 clearance
• Fred Sammons, Inc.1 clearance
• Dow Corning Wright1 clearance
• David Hendricks, C.P.O.1 clearance
• Danek Medical, Inc.1 clearance
• Buckman Consultants1 clearance

• K823882 — M-BRACEBuckman Consultants·1983-01-17
• K823823 — LUMBOSACRAL SUPPORTDanek Medical, Inc.·1983-01-14
• K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSISSurgical Appliance Industries, Inc.·1981-09-14
• K812099 — CASH ORTHOSISDavid Hendricks, C.P.O.·1981-08-13
• K811494 — LUMBO-SACRAL FLEXION ORTHOSISSurgical Appliance Industries, Inc.·1981-06-16
• K810554 — LUMBAR FLEXION BRACEOrthomedics·1981-03-13
• K810556 — SPINAL EXTENSION BRACEOrthomedics·1981-03-13
• K803033 — CRUSADER HYPEREXTENSION BRACEOrthomedics·1980-12-22
• K801712 — LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SACFred Sammons, Inc.·1980-08-07
• K792269 — WRIGHT DOW CORNING SOFTGOODS W/DOWDow Corning Wright·1980-02-05
• K791314 — VERTEBRACE SPINAL SUPPORTSVertebrace, Inc.·1979-07-30