510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K912634Substantially Equivalent

Cordless Electric Massager Ev315

Matsushita Electric Co., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912634 is the FDA 510(k) clearance record for CORDLESS ELECTRIC MASSAGER EV315, a class I device, cleared for Matsushita Electric Co. on under FDA product code ISA (Massager, Therapeutic, Electric). FDA records list 2 510(k) clearances for Matsushita Electric Co., from to . As of , FDA records show no recalls naming K912634.

Clearance record

Decision date
Received
(90 days to decision)
Product code
ISA Massager, Therapeutic, Electric
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Matsushita Electric Co. 1730 Pennsylvania Ave., NW, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code ISA

Trailing 12 months

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

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