Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MARK IV HAND, THUMB AND WRIST (CPM) UNIT

K-Number: K894907 · 1989-10-06

ApplicantInnovative Medical Engineering, Inc.
Decision Date1989-10-06
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MARK IV HAND, THUMB AND WRIST (CPM) UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Medical Engineering, Inc.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K894907. 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 MARK IV HAND, THUMB AND WRIST (CPM) UNIT?

MARK IV HAND, THUMB AND WRIST (CPM) UNIT is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Innovative Medical Engineering, Inc.. The 510(k) number is K894907.

When did MARK IV HAND, THUMB AND WRIST (CPM) UNIT receive FDA 510(k) clearance?

MARK IV HAND, THUMB AND WRIST (CPM) UNIT received FDA 510(k) clearance on 1989-10-06, under 510(k) number K894907.

Who is the listed applicant for MARK IV HAND, THUMB AND WRIST (CPM) UNIT?

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

What is the FDA product code for MARK IV HAND, THUMB AND WRIST (CPM) UNIT?

The FDA product code for MARK IV HAND, THUMB AND WRIST (CPM) UNIT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Innovative Medical Engineering, 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.

K902600THE COMPANION NON-ELECTRIC LIFT CHAIR

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.

↑