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)

ACTIC 2002

K-Number: K946169 · 1995-06-15

ApplicantNorth Atlantic Rehabilitation, Inc.
Decision Date1995-06-15
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACTIC 2002 is the device name listed in this FDA 510(k) record. The listed applicant is North Atlantic Rehabilitation, Inc.. It received FDA 510(k) clearance on 1995-06-15 under 510(k) number K946169. 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 ACTIC 2002?

ACTIC 2002 is a medical device that received FDA 510(k) clearance on 1995-06-15. The listed applicant is North Atlantic Rehabilitation, Inc.. The 510(k) number is K946169.

When did ACTIC 2002 receive FDA 510(k) clearance?

ACTIC 2002 received FDA 510(k) clearance on 1995-06-15, under 510(k) number K946169.

Who is the listed applicant for ACTIC 2002?

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

What is the FDA product code for ACTIC 2002?

The FDA product code for ACTIC 2002 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

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.

↑