Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PNEU-WAVE

K-Number: K911574 · 1991-10-02

ApplicantPneu-Mobility, Inc.
Decision Date1991-10-02
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PNEU-WAVE is the device name listed in this FDA 510(k) record. The listed applicant is Pneu-Mobility, Inc.. It received FDA 510(k) clearance on 1991-10-02 under 510(k) number K911574. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEU-WAVE?

PNEU-WAVE is a medical device that received FDA 510(k) clearance on 1991-10-02. The listed applicant is Pneu-Mobility, Inc.. The 510(k) number is K911574.

When did PNEU-WAVE receive FDA 510(k) clearance?

PNEU-WAVE received FDA 510(k) clearance on 1991-10-02, under 510(k) number K911574.

Who is the listed applicant for PNEU-WAVE?

The FDA 510(k) record lists Pneu-Mobility, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PNEU-WAVE?

The FDA product code for PNEU-WAVE is JFB.

Related Devices (Code: JFB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250266Ceragem Automatic Thermal Massager (CGM MB-2401)Ceragem Co., Ltd.K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)Marzzan Lucas JorgeK243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)Ceragem Co., Ltd.K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd.K240168N7-SNuga Medical Co., Ltd.K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑