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

Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

21 CFR 890.5290 / Physical Medicine
FDA source (opens on fda.gov)

PQY is the FDA product code for Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain, a class II device type, regulated under 21 CFR 890.5290. FDA's definition for this code reads: "Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PQY
Device name
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
FDA definition
Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.
Regulation
21 CFR 890.5290
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PQY

By decision year
2 clearances under product code PQY with a decision year between 2017 and 2020, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PQY by decision year
YearClearances
20171
20201

Applicants with the most clearances

Product code PQY
Applicants holding the most 510(k) clearances under product code PQY
ApplicantClearances
Bioelectronics Corporation2

Companies listing this code with FDA

Companies whose registered establishments list this code