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)

RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300

K-Number: K880865 · 1988-05-02

ApplicantInvacare Corp.
Decision Date1988-05-02
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 1988-05-02 under 510(k) number K880865. 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 RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300?

RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 is a medical device that received FDA 510(k) clearance on 1988-05-02. The listed applicant is Invacare Corp.. The 510(k) number is K880865.

When did RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 receive FDA 510(k) clearance?

RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 received FDA 510(k) clearance on 1988-05-02, under 510(k) number K880865.

Who is the listed applicant for RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300?

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

What is the FDA product code for RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300?

The FDA product code for RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 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 Invacare Corp. 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.

K071928THE INVACARE FLYER, MODEL IPC 100K070321TWILIGHT FULL FACE MASKK062402EASYSTAND EVOLVK061874INVACARE'S TWILIGHT II NASAL MASKSK033819INVACARE 3G TARSYSK031176INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000

View all 111 devices →

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.

↑