510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953352Substantially Equivalent

Proteam Cushion

Iskra.Med, Great Neck, NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953352 is the FDA 510(k) clearance record for PROTEAM CUSHION, a class I device, cleared for Iskra.Med on under FDA product code KIC (Cushion, Flotation). FDA records list one 510(k) clearance for Iskra.Med. As of , FDA records show no recalls naming K953352.

Clearance record

Decision date
Received
(135 days to decision)
Product code
KIC Cushion, Flotation
Regulation
21 CFR 890.3175
Device class
Class I
Review panel
Physical Medicine
Applicant
Iskra.Med 55 Northern Blvd., Suite 410, Great Neck, NY
510(k) summary
Statement
Third party review
No

Clearances, product code KIC

Trailing 12 months

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

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