510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K213188Substantially Equivalent

Primary Relief

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

K213188 is the FDA 510(k) clearance record for Primary Relief, a class II device, cleared for Dyansys, Inc. on under FDA product code NHI (Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief). FDA's definition for product code NHI reads: "Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver...". FDA records list 15 510(k) clearances for Dyansys, Inc., from to . As of , FDA records show no recalls naming K213188.

Clearance record

Decision date
Received
(124 days to decision)
Product code
NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Regulation
21 CFR 882.5890
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 NHI

Trailing 12 months

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

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