510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K864558Substantially Equivalent for Some Indications

U66 Ems

Suntec Health & Fitness Group, Inc., North Palm Beach FL / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K864558 is the FDA 510(k) clearance record for U66 EMS, a class II device, cleared for Suntec Health & Fitness Group, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 2 510(k) clearances for Suntec Health & Fitness Group, Inc., from to . As of , FDA records show no recalls naming K864558.

Clearance record

Decision date
Received
(59 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Suntec Health & Fitness Group, Inc. Crystal Tree Plz., North Palm Beach FL
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