510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871421Substantially Equivalent

Model Hl-100 Portable Dc Elect. Therapeutic Unit

Futuremed Div. of Future Impex Corp., Deerpark NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871421 is the FDA 510(k) clearance record for MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT, a class II device, cleared for Futuremed Div. of Future Impex Corp. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 17 510(k) clearances for Futuremed Div. of Future Impex Corp., from to . As of , FDA records show no recalls naming K871421.

Clearance record

Decision date
Received
(288 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Futuremed Div. of Future Impex Corp. 2076 Deer Park Ave., Deerpark NY
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