510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860289Substantially Equivalent

Phd-36 Physiological Signal Amplifier

Professional Health Technologies, Inc., Del Mar CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860289 is the FDA 510(k) clearance record for PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER, a class II device, cleared for Professional Health Technologies, Inc. on under FDA product code GWL (Amplifier, Physiological Signal). FDA records list one 510(k) clearance for Professional Health Technologies, Inc. As of , FDA records show no recalls naming K860289.

Clearance record

Decision date
Received
(209 days to decision)
Product code
GWL Amplifier, Physiological Signal
Regulation
21 CFR 882.1835
Device class
Class II
Review panel
Neurology
Applicant
Professional Health Technologies, Inc. 915 Camino Del Mar, Suite 100, Del Mar CA
Third party review
No

Clearances, product code GWL

Trailing 12 months

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

FDA records show no clearances under product code GWL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWL, 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