510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K000655Substantially Equivalent

Ppcid- Pneumatic Peripheral Circulation Improvement (Footrest) Device

Ahava Stein, Ginot Shomron, 44853, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000655 is the FDA 510(k) clearance record for PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE, a class II device, cleared for Ahava Stein on under FDA product code IRP (Massager, Powered Inflatable Tube). FDA records list one 510(k) clearance for Ahava Stein. As of , FDA records show no recalls naming K000655.

Clearance record

Decision date
Received
(392 days to decision)
Product code
IRP Massager, Powered Inflatable Tube
Regulation
21 CFR 890.5650
Device class
Class II
Review panel
Physical Medicine
Applicant
Ahava Stein P.o.b. 454, Ginot Shomron, 44853, IL
510(k) summary
Statement
Third party review
No

Clearances, product code IRP

Trailing 12 months
11 clearances under product code IRP in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code IRP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20263
May 20262
June 20261
July 20262
August 20261
September 20260
October 20260