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FDA 510(k)

KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE

K-Number: K850332 · 1985-05-01

ApplicantRichards Medical Co., Inc.
Decision Date1985-05-01
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1985-05-01 under 510(k) number K850332. 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 KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE?

KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE is a medical device that received FDA 510(k) clearance on 1985-05-01. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K850332.

When did KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE receive FDA 510(k) clearance?

KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE received FDA 510(k) clearance on 1985-05-01, under 510(k) number K850332.

Who is the listed applicant for KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE?

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

What is the FDA product code for KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE?

The FDA product code for KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE is BXB.

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Other records listing Richards Medical Co., 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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZES

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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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