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510(k) DEN170028

Cala ONE by Cala Health, Inc. — Product Code QBC

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 26, 2018
Date Received
May 17, 2017
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Upper Limb Tremor Stimulator
Device Class
Class II
Regulation Number
882.5897
Review Panel
NE
Submission Type

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.

Other clearances by Cala Health, Inc.

  • K243848 — Cala kIQ (January 16, 2025)
  • K242259 — Cala kIQ (November 22, 2024)
  • K222237 — Cala kIQ (November 22, 2022)
  • K203288 — Cala Trio (October 5, 2021)
  • K182706 — External upper limb tremor stimulator (October 25, 2018)

Other clearances for product code QBC

  • K251517 — Encora X1 (February 5, 2026)
  • K250096 — Felix NeuroAI System (July 1, 2025)
  • K243848 — Cala kIQ (January 16, 2025)
  • K242259 — Cala kIQ (November 22, 2024)
  • K222237 — Cala kIQ (November 22, 2022)
  • K203288 — Cala Trio (October 5, 2021)
  • K182706 — External upper limb tremor stimulator (October 25, 2018)