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FDA 510(k)

ARTICULAR MOTION DEVICE (AMD4000)

K-Number: K863639 · 1986-09-29

ApplicantMed Surg Designs, Inc.
Decision Date1986-09-29
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ARTICULAR MOTION DEVICE (AMD4000) is the device name listed in this FDA 510(k) record. The listed applicant is Med Surg Designs, Inc.. It received FDA 510(k) clearance on 1986-09-29 under 510(k) number K863639. 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 ARTICULAR MOTION DEVICE (AMD4000)?

ARTICULAR MOTION DEVICE (AMD4000) is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is Med Surg Designs, Inc.. The 510(k) number is K863639.

When did ARTICULAR MOTION DEVICE (AMD4000) receive FDA 510(k) clearance?

ARTICULAR MOTION DEVICE (AMD4000) received FDA 510(k) clearance on 1986-09-29, under 510(k) number K863639.

Who is the listed applicant for ARTICULAR MOTION DEVICE (AMD4000)?

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

What is the FDA product code for ARTICULAR MOTION DEVICE (AMD4000)?

The FDA product code for ARTICULAR MOTION DEVICE (AMD4000) is BXB.

Related Clinical Trials

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.

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Other records listing Med Surg Designs, 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.

K850122SONI-LOK SCOPE STABILIZER

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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