510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K901796Substantially Equivalent

Podoflex Exerciser-Passive-Foot/ankle

Component Equipment Mfg., Inc., Colorado Springs CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901796 is the FDA 510(k) clearance record for PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE, a class I device, cleared for Component Equipment Mfg., Inc. on under FDA product code ISA (Massager, Therapeutic, Electric). FDA records list 2 510(k) clearances for Component Equipment Mfg., Inc., from to . As of , FDA records show no recalls naming K901796.

Clearance record

Decision date
Received
(48 days to decision)
Product code
ISA Massager, Therapeutic, Electric
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Component Equipment Mfg., Inc. 615 Conrad St., Colorado Springs CO
Third party review
No

Clearances, product code ISA

Trailing 12 months

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

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