510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143512Substantially Equivalent

ActiSpec Activity Monitor

Sleep Modus, Inc., Richardson TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143512 is the FDA 510(k) clearance record for ActiSpec Activity Monitor, a class II device, cleared for Sleep Modus, Inc. on under FDA product code ISD (Exerciser, Measuring). FDA records list one 510(k) clearance for Sleep Modus, Inc. As of , FDA records show no recalls naming K143512.

Clearance record

Decision date
Received
(258 days to decision)
Product code
ISD Exerciser, Measuring
Regulation
21 CFR 890.5360
Device class
Class II
Review panel
Physical Medicine
Applicant
Sleep Modus, Inc. 1201 Richardson Dr., Suite 280-B, Richardson TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ISD

Trailing 12 months

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

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