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

Aid, Vision, Electronic, Battery-Powered

21 CFR 886.5900 / Ophthalmic
FDA source (opens on fda.gov)

HPG is the FDA product code for Aid, Vision, Electronic, Battery-Powered, a class I device type, regulated under 21 CFR 886.5900. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HPG
Device name
Aid, Vision, Electronic, Battery-Powered
Regulation
21 CFR 886.5900
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code HPG

By decision year
7 clearances under product code HPG with a decision year between 1976 and 1991, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HPG by decision year
YearClearances
19761
19831
19861
19902
19912

Applicants with the most clearances

Product code HPG
Applicants holding the most 510(k) clearances under product code HPG
ApplicantClearances
Nurion Industries3
Brytech, Inc.1
Itt Corp.1
Oms1
Triangle Investments1

Companies listing this code with FDA

Companies whose registered establishments list this code