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510(k) K823882

M-BRACE by Buckman Consultants — Product Code IPY

K823882 is an FDA 510(k) premarket notification submitted by Buckman Consultants for the device "M-BRACE". The FDA issued a decision of Substantially Equivalent on January 17, 1983. The device falls under product code IPY (Orthosis, Lumbo-Sacral), a Class I device regulated under 21 CFR 890.3490. Buckman Consultants has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1983
Date Received
December 27, 1982
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 by Buckman Consultants

  • K830316 — UNIFLEX (March 24, 1983)
  • K821829 — UROGARD (July 30, 1982)

Other clearances for product code IPY

  • K823823 — LUMBOSACRAL SUPPORT (January 14, 1983)
  • K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (September 14, 1981)
  • K812099 — CASH ORTHOSIS (August 13, 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