510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170028Unknown

Cala ONE

Cala Health, Inc., Burlingame CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN170028 is the FDA 510(k) clearance record for Cala ONE, a class II device, cleared for Cala Health, Inc. on under FDA product code QBC (External Upper Limb Tremor Stimulator). FDA's definition for product code QBC reads: "An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb". FDA records list 7 510(k) clearances for Cala Health, Inc., from to . As of , FDA records show no recalls naming DEN170028.

Clearance record

Decision date
Received
(344 days to decision)
Product code
QBC External Upper Limb Tremor Stimulator
Regulation
21 CFR 882.5897
Device class
Class II
Review panel
Neurology
Applicant
Cala Health, Inc. 875 Mahler Rd., Suite 168, Burlingame CA
Third party review
No

Clearances, product code QBC

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