510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770086Substantially Equivalent

Sanar

Health Improvement Assoc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770086 is the FDA 510(k) clearance record for SANAR, a class II device, cleared for Health Improvement Assoc. on under FDA product code IMB (Cabinet, Moist Steam). FDA records list 4 510(k) clearances for Health Improvement Assoc., from to . As of , FDA records show no recalls naming K770086.

Clearance record

Decision date
Received
(94 days to decision)
Product code
IMB Cabinet, Moist Steam
Regulation
21 CFR 890.5250
Device class
Class II
Review panel
Physical Medicine
Applicant
Health Improvement Assoc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IMB

Trailing 12 months

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

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