510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052289Substantially Equivalent

Deepwave Neuromodulation Pain Therapy Device

Biowave Corporation, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052289 is the FDA 510(k) clearance record for DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE, a class II device, cleared for Biowave Corporation on under FDA product code LIH (Interferential Current Therapy). FDA records list 8 510(k) clearances for Biowave Corporation, from to . As of , FDA records show no recalls naming K052289.

Clearance record

Decision date
Received
(112 days to decision)
Product code
LIH Interferential Current Therapy
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Biowave Corporation 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LIH

Trailing 12 months

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

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