510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871107Substantially Equivalent for Some Indications

Vasotrain 447

Henley Intl., Houston TX / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K871107 is the FDA 510(k) clearance record for VASOTRAIN 447, a class I device, cleared for Henley Intl. on under FDA product code IRO (Vibrator, Therapeutic). FDA records list 44 510(k) clearances for Henley Intl., from to . As of , FDA records show no recalls naming K871107.

Clearance record

Decision date
Received
(71 days to decision)
Product code
IRO Vibrator, Therapeutic
Regulation
21 CFR 890.5975
Device class
Class I
Review panel
Physical Medicine
Applicant
Henley Intl. 10518 Kinghurst, Houston TX
Third party review
No

Clearances, product code IRO

Trailing 12 months

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

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