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FDA 510(k)

FLEXMATE K500

K-Number: K950755 · 1995-10-05

ApplicantBreg, Inc.
Decision Date1995-10-05
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FLEXMATE K500 is the device name listed in this FDA 510(k) record. The listed applicant is Breg, Inc.. It received FDA 510(k) clearance on 1995-10-05 under 510(k) number K950755. 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 FLEXMATE K500?

FLEXMATE K500 is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is Breg, Inc.. The 510(k) number is K950755.

When did FLEXMATE K500 receive FDA 510(k) clearance?

FLEXMATE K500 received FDA 510(k) clearance on 1995-10-05, under 510(k) number K950755.

Who is the listed applicant for FLEXMATE K500?

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

What is the FDA product code for FLEXMATE K500?

The FDA product code for FLEXMATE K500 is BXB.

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Other records listing Breg, Inc. 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.

K183702Polar Care WaveK070402MODIFICATION TO POLAR CARE 500K041714E-PAIN CAREK020988PAIN CARE 4200K013928PAIN CARE 3200K003611PAIN CARE MULTI-PORT CATHETER, MODEL 2000L

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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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