510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K904242Substantially Equivalent

Qi-Gong Machine Therapeutic Massager

China Healthways Institute, San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904242 is the FDA 510(k) clearance record for QI-GONG MACHINE THERAPEUTIC MASSAGER, a class I device, cleared for China Healthways Institute on under FDA product code ISA (Massager, Therapeutic, Electric). FDA records list one 510(k) clearance for China Healthways Institute. As of , FDA records show no recalls naming K904242.

Clearance record

Decision date
Received
(24 days to decision)
Product code
ISA Massager, Therapeutic, Electric
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
China Healthways Institute 155 Del Mar, San Clemente 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