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
K861091Substantially Equivalent

Easistim

Promed Corp., Larkspur CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861091 is the FDA 510(k) clearance record for EASISTIM, a class II device, cleared for Promed Corp. on under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric). FDA records list 4 510(k) clearances for Promed Corp., from to . As of , FDA records show no recalls naming K861091.

Clearance record

Decision date
Received
(70 days to decision)
Product code
KOI Stimulator, Nerve, Peripheral, Electric
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Promed Corp. 700 Larkspur Landing Cir., Larkspur CA
Third party review
No

Clearances, product code KOI

Trailing 12 months
1 clearance under product code KOI in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260