510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K945603Substantially Equivalent for Some Indications

Cordless Massager with Heat ( Various Brand Names)

Headwaters, Inc., Cambridge MA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K945603 is the FDA 510(k) clearance record for CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES), a class I device, cleared for Headwaters, Inc. on under FDA product code IRO (Vibrator, Therapeutic). FDA records list one 510(k) clearance for Headwaters, Inc. As of , FDA records show no recalls naming K945603.

Clearance record

Decision date
Received
(86 days to decision)
Product code
IRO Vibrator, Therapeutic
Regulation
21 CFR 890.5975
Device class
Class I
Review panel
Physical Medicine
Applicant
Headwaters, Inc. 10 Rogers St., Suite 214, Cambridge MA
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