510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882816Substantially Equivalent

Pulsar Em

Apex Medical, Inc., Martinsville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882816 is the FDA 510(k) clearance record for PULSAR EM, a class II device, cleared for Apex Medical, Inc. on under FDA product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat). FDA records list 36 510(k) clearances for Apex Medical, Inc., from to . As of , FDA records show no recalls naming K882816.

Clearance record

Decision date
Received
(293 days to decision)
Product code
ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5290
Device class
Class II
Review panel
Physical Medicine
Applicant
Apex Medical, Inc. 990 Dillman Rd., Martinsville IN
Third party review
No

Clearances, product code ILX

Trailing 12 months

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

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