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FDA 510(k)

ROMFLEX

K-Number: K905718 · 1991-02-19

ApplicantParaflex Corp.
Decision Date1991-02-19
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ROMFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Paraflex Corp.. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K905718. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROMFLEX?

ROMFLEX is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Paraflex Corp.. The 510(k) number is K905718.

When did ROMFLEX receive FDA 510(k) clearance?

ROMFLEX received FDA 510(k) clearance on 1991-02-19, under 510(k) number K905718.

Who is the listed applicant for ROMFLEX?

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

What is the FDA product code for ROMFLEX?

The FDA product code for ROMFLEX is BXB.

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Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.

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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