510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950656Substantially Equivalent

Ped Alert

Orbitec Technologies Corp., Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950656 is the FDA 510(k) clearance record for PED ALERT, a class II device, cleared for Orbitec Technologies Corp. on under FDA product code IRN (Device, Warning, Overload, External Limb, Powered). FDA records list one 510(k) clearance for Orbitec Technologies Corp. As of , FDA records show no recalls naming K950656.

Clearance record

Decision date
Received
(254 days to decision)
Product code
IRN Device, Warning, Overload, External Limb, Powered
Regulation
21 CFR 890.5575
Device class
Class II
Review panel
Physical Medicine
Applicant
Orbitec Technologies Corp. 402 Gammon Pl., Madison WI
510(k) summary
Statement
Third party review
No

Clearances, product code IRN

Trailing 12 months

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

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