510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K864088Substantially Equivalent

Hitachi Hand Held Massager A/c Powered

Hitachi Sales Corporation of America, Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864088 is the FDA 510(k) clearance record for HITACHI HAND HELD MASSAGER A/C POWERED, a class I device, cleared for Hitachi Sales Corporation of America on under FDA product code ISA (Massager, Therapeutic, Electric). FDA records list 2 510(k) clearances for Hitachi Sales Corporation of America, from to . As of , FDA records show no recalls naming K864088.

Clearance record

Decision date
Received
(13 days to decision)
Product code
ISA Massager, Therapeutic, Electric
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Hitachi Sales Corporation of America P.O. Box 92232, Los Angeles CA
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