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510(k) K812099

CASH ORTHOSIS by David Hendricks, C.P.O. — Product Code IPY

K812099 is an FDA 510(k) premarket notification submitted by David Hendricks, C.P.O. for the device "CASH ORTHOSIS". The FDA issued a decision of Substantially Equivalent on August 13, 1981. The device falls under product code IPY (Orthosis, Lumbo-Sacral), a Class I device regulated under 21 CFR 890.3490.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1981
Date Received
July 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Lumbo-Sacral
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances for product code IPY

  • K823882 — M-BRACE (January 17, 1983)
  • K823823 — LUMBOSACRAL SUPPORT (January 14, 1983)
  • K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (September 14, 1981)
  • K811494 — LUMBO-SACRAL FLEXION ORTHOSIS (June 16, 1981)
  • K810554 — LUMBAR FLEXION BRACE (March 13, 1981)
  • K810556 — SPINAL EXTENSION BRACE (March 13, 1981)
  • K803033 — CRUSADER HYPEREXTENSION BRACE (December 22, 1980)
  • K801712 — LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC (August 7, 1980)
  • K792269 — WRIGHT DOW CORNING SOFTGOODS W/DOW (February 5, 1980)
  • K791314 — VERTEBRACE SPINAL SUPPORTS (July 30, 1979)

FDA data resources