M-BRACE— 510(k) K823882

Substantially Equivalent

Buckman Consultants

FDA 510(k) clearance K823882 for M-BRACE, Substantially Equivalent on 1983-01-17. Applicant: Buckman Consultants. Device class: 1.

Clearance details

Applicant: Buckman Consultants
Product code: Code IPY
Device class: Class 1
Regulation: 21 CFR 890.3490
Advisory panel: Physical Medicine
Date received: 1982-12-27
Decision date: 1983-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IPY

K823823 — LUMBOSACRAL SUPPORT1983-01-14
K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS1981-09-14
K812099 — CASH ORTHOSIS1981-08-13
K811494 — LUMBO-SACRAL FLEXION ORTHOSIS1981-06-16
K810554 — LUMBAR FLEXION BRACE1981-03-13

More clearances from Buckman Consultants

K830316 — UNIFLEX1983-03-24
K821829 — UROGARD1982-07-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.