510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800526Substantially Equivalent

Smr H-Chair

Surgical Mechanical Research, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800526 is the FDA 510(k) clearance record for SMR H-CHAIR, a class I device, cleared for Surgical Mechanical Research, Inc. on under FDA product code ETF (Unit, Examining/Treatment, Ent). FDA records list 4 510(k) clearances for Surgical Mechanical Research, Inc., from to . As of , FDA records show no recalls naming K800526.

Clearance record

Decision date
Received
(11 days to decision)
Product code
ETF Unit, Examining/Treatment, Ent
Regulation
21 CFR 874.5300
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Surgical Mechanical Research, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ETF

Trailing 12 months

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

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