510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954162Substantially Equivalent

Ergoseat System

Ergo-Air, Inc., Marblehead MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954162 is the FDA 510(k) clearance record for ERGOSEAT SYSTEM, a class II device, cleared for Ergo-Air, Inc. on under FDA product code MOC (Cushion, Flotation, Therapeutic). FDA records list 3 510(k) clearances for Ergo-Air, Inc., from to . As of , FDA records show no recalls naming K954162.

Clearance record

Decision date
Received
(55 days to decision)
Product code
MOC Cushion, Flotation, Therapeutic
Regulation
21 CFR 890.5170
Device class
Class II
Review panel
Physical Medicine
Applicant
Ergo-Air, Inc. 24 Watson St., Marblehead MA
510(k) summary
Statement
Third party review
No

Clearances, product code MOC

Trailing 12 months

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

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