510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250005Unknown

Sana Device

Sana Health, Inc., Louisville CO / Direct, Unknown
FDA source (opens on fda.gov)

DEN250005 is the FDA 510(k) clearance record for Sana Device, a class I device, cleared for Sana Health on under FDA product code QYN (Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)). FDA's definition for product code QYN reads: "An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies". FDA records list one 510(k) clearance for Sana Health. As of , FDA records show no recalls naming DEN250005.

Clearance record

Decision date
Received
(319 days to decision)
Product code
QYN Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
Regulation
21 CFR 890.5775
Device class
Class I
Review panel
Physical Medicine
Applicant
Sana Health 2051 Dogwood St., Suite 220, Louisville CO
Third party review
No

Clearances, product code QYN

Trailing 12 months
1 clearance under product code QYN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QYN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260