510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K915729Substantially Equivalent

Auqasoothe/aqua Med

Aquasoothe, Kannapolis NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915729 is the FDA 510(k) clearance record for AUQASOOTHE/AQUA MED, a class I device, cleared for Aquasoothe on under FDA product code ISA (Massager, Therapeutic, Electric). FDA records list one 510(k) clearance for Aquasoothe. As of , FDA records show no recalls naming K915729.

Clearance record

Decision date
Received
(131 days to decision)
Product code
ISA Massager, Therapeutic, Electric
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Aquasoothe 2808 Concord Lake Rd., Kannapolis NC
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