510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K940582Substantially Equivalent for Some Indications

Massaging Helmet C.f. Hansen Design

Philco Ushuaia, Canada, CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K940582 is the FDA 510(k) clearance record for MASSAGING HELMET C.F. HANSEN DESIGN, a class I device, cleared for Philco Ushuaia on under FDA product code IRO (Vibrator, Therapeutic). FDA records list one 510(k) clearance for Philco Ushuaia. As of , FDA records show no recalls naming K940582.

Clearance record

Decision date
Received
(356 days to decision)
Product code
IRO Vibrator, Therapeutic
Regulation
21 CFR 890.5975
Device class
Class I
Review panel
Physical Medicine
Applicant
Philco Ushuaia 4881 Yonge St., Suite 602, Canada, CA
Third party review
No

Clearances, product code IRO

Trailing 12 months

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

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