510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011588Substantially Equivalent

Suretone

Suretone International, Cape Town, Cape, ZA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011588 is the FDA 510(k) clearance record for SURETONE, a class II device, cleared for Suretone International on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list one 510(k) clearance for Suretone International. As of , FDA records show no recalls naming K011588.

Clearance record

Decision date
Received
(309 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Suretone International 2 Presedent Brand St., Cape Town, Cape, ZA
510(k) summary
Statement
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260