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FDA 510(k)

Mobility+ Enteral Feeding System OTC

K-Number: K233034 · 2024-04-12

ApplicantRockfield Medical
Decision Date2024-04-12
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Mobility+ Enteral Feeding System OTC is the device name listed in this FDA 510(k) record. The listed applicant is Rockfield Medical. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K233034. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mobility+ Enteral Feeding System OTC?

Mobility+ Enteral Feeding System OTC is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Rockfield Medical. The 510(k) number is K233034.

When did Mobility+ Enteral Feeding System OTC receive FDA 510(k) clearance?

Mobility+ Enteral Feeding System OTC received FDA 510(k) clearance on 2024-04-12, under 510(k) number K233034.

Who is the listed applicant for Mobility+ Enteral Feeding System OTC?

The FDA 510(k) record lists Rockfield Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mobility+ Enteral Feeding System OTC?

The FDA product code for Mobility+ Enteral Feeding System OTC is PIF.

Other records listing Rockfield Medical as applicant

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.

K222678Mobility+ Enteral Feeding System

Related Devices (Code: PIF)

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.

K254170Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone , Ltd.K242917Enteral Drainage System, Enteral Medicine strawHMC Premedical S.p.A.K250481Extension Feeding Set with ENFit™ ConnectorsSKY Medical, a.s.K240052Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd.K230326ENFit to ENFit Extension SetsVesco MedicalK232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT ConnectionXeridiem Medical Devices, A Spectrum Plastics Group Company

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.

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