510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211971Substantially Equivalent

Drug Relief v1

Dyansys, Inc., San Mateo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211971 is the FDA 510(k) clearance record for Drug Relief v1, a class II device, cleared for Dyansys, Inc. on under FDA product code PZR (Percutaneous Nerve Stimulator For Opioid Withdrawal). FDA's definition for product code PZR reads: "Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders". FDA records list 15 510(k) clearances for Dyansys, Inc., from to . As of , FDA records show no recalls naming K211971.

Clearance record

Decision date
Received
(134 days to decision)
Product code
PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Regulation
21 CFR 882.5896
Device class
Class II
Review panel
Neurology
Applicant
Dyansys, Inc. 300, N. Bayshore Blvd., San Mateo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZR

Trailing 12 months

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

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