510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K912320Substantially Equivalent

Biophysiometer Positioning Chair

Bi-Dynamics, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912320 is the FDA 510(k) clearance record for BIOPHYSIOMETER POSITIONING CHAIR, a class II device, cleared for Bi-Dynamics, Inc. on under FDA product code INO (Chair, Positioning, Electric). FDA records list one 510(k) clearance for Bi-Dynamics, Inc. As of , FDA records show no recalls naming K912320.

Clearance record

Decision date
Received
(90 days to decision)
Product code
INO Chair, Positioning, Electric
Regulation
21 CFR 890.3110
Device class
Class II
Review panel
Physical Medicine
Applicant
Bi-Dynamics, Inc. C/O Hogan & Hartson, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code INO

Trailing 12 months

FDA records hold no clearances under product code INO in the trailing twelve months.

FDA records show no clearances under product code INO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code INO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260