510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111557Substantially Equivalent

X-Force

Seven Seas Distribtion and Manufacturing, LLC, Las Vegas NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111557 is the FDA 510(k) clearance record for X-FORCE, a class II device, cleared for Seven Seas Distribtion and Manufacturing, LLC on under FDA product code NYN (Stimulator, Electrical, Transcutaneous, For Arthritis). FDA's definition for product code NYN reads: "Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis)". FDA records list one 510(k) clearance for Seven Seas Distribtion and Manufacturing, LLC. As of , FDA records show no recalls naming K111557.

Clearance record

Decision date
Received
(160 days to decision)
Product code
NYN Stimulator, Electrical, Transcutaneous, For Arthritis
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Seven Seas Distribtion and Manufacturing, LLC 2620 S Maryland Pkwy., Las Vegas NV
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NYN

Trailing 12 months

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

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