510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083322Substantially Equivalent

Neurometrix Bioamplifier

Neurometrix, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083322 is the FDA 510(k) clearance record for NEUROMETRIX BIOAMPLIFIER, a class II device, cleared for Neurometrix, Inc. on under FDA product code GWL (Amplifier, Physiological Signal). FDA records list 18 510(k) clearances for Neurometrix, Inc., from to . As of , FDA records show no recalls naming K083322.

Clearance record

Decision date
Received
(196 days to decision)
Product code
GWL Amplifier, Physiological Signal
Regulation
21 CFR 882.1835
Device class
Class II
Review panel
Neurology
Applicant
Neurometrix, Inc. 62 Fourth Ave., Waltham MA
510(k) summary
Summary PDF
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