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

External Upper Limb Tremor Stimulator

21 CFR 882.5897 / Neurology
FDA source (opens on fda.gov)

QBC is the FDA product code for External Upper Limb Tremor Stimulator, a class II device type, regulated under 21 CFR 882.5897. FDA's definition for this code 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". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QBC
Device name
External Upper Limb Tremor Stimulator
FDA definition
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.
Regulation
21 CFR 882.5897
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code QBC

By decision year
9 clearances under product code QBC with a decision year between 2018 and 2026, 2018 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QBC by decision year
YearClearances
20182
20211
20221
20241
20252
20262

Applicants with the most clearances

Product code QBC
Applicants holding the most 510(k) clearances under product code QBC
ApplicantClearances
Cala Health, Inc.7
Encora, Inc1
Fasikl Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code