FDA applicant

Performance Plus, Inc.

Great Neck, NY1 decision1998–19980 recalls

FDA records 1 decision for Performance Plus, Inc. (Great Neck, NY) in 1998: 1 510(k) clearance. All are in product code LKY (Device, External Penile Rigidity). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Performance Plus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Performance Plus, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Performance Plus, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Performance”

FDA records each applicant name separately; these may or may not be the same firm.

Performance Surgical Instruments Corp. 2 Performance Medical, Inc. 1 Performance Instruments Corp. 1 Performance, Inc. 1 Performance Hyperbarics 1 Performance Water Systems, LLC 1 Performance Ent. 1

Performance Plus, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Performance”