510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K851046Substantially Equivalent for Some Indications

Myocare Plus Dual Channel Stimulator

3M Company, Cottae Grove MN / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K851046 is the FDA 510(k) clearance record for MYOCARE PLUS DUAL CHANNEL STIMULATOR, a class II device, cleared for 3M Company on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 63 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming K851046.

Clearance record

Decision date
Received
(109 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
3M Company Chemolite Blvd. & Washington, Cottae Grove MN
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260