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

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

21 CFR 878.4685 / General, Plastic Surgery
FDA source (opens on fda.gov)

PZL is the FDA product code for Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers, a class II device type, regulated under 21 CFR 878.4685. FDA's definition for this code reads: "Treatment of diabetic foot ulcers". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PZL
Device name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
FDA definition
Treatment of diabetic foot ulcers
Regulation
21 CFR 878.4685
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code PZL

By decision year
8 clearances under product code PZL with a decision year between 2017 and 2025, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PZL by decision year
YearClearances
20171
20191
20201
20211
20231
20241
20252

Applicants with the most clearances

Product code PZL
Applicants holding the most 510(k) clearances under product code PZL
ApplicantClearances
Softwave/Trt, LLC2
Tissue Regeneration Technologies2
Curative Sound Therapeutics, Inc.1
E.M.S. - Electro Medical Systems SA1
Sanuwave, Inc.1
Storz Medical AG1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order