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

Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

21 CFR 882.5804 / Neurology
FDA source (opens on fda.gov)

QWI is the FDA product code for Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms, a class II device type, regulated under 21 CFR 882.5804. FDA's definition for this code reads: "Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QWI
Device name
Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
FDA definition
Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms
Regulation
21 CFR 882.5804
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
1
Ingested recalls
0

Clearances, product code QWI

By decision year
1 clearance under product code QWI with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QWI by decision year
YearClearances
20231

Applicants with the most clearances

Product code QWI
Applicants holding the most 510(k) clearances under product code QWI
ApplicantClearances
Swing Therapeutics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code