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)

CYCLOPAC TENS

K-Number: K801855 · 1980-08-13

ApplicantDow Corning Wright
Decision Date1980-08-13
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CYCLOPAC TENS is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Wright. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801855. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYCLOPAC TENS?

CYCLOPAC TENS is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is Dow Corning Wright. The 510(k) number is K801855.

When did CYCLOPAC TENS receive FDA 510(k) clearance?

CYCLOPAC TENS received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801855.

Who is the listed applicant for CYCLOPAC TENS?

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

What is the FDA product code for CYCLOPAC TENS?

The FDA product code for CYCLOPAC TENS is GZT.

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 Dow Corning Wright 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.

K932210ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENTK932911ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENTK934354LACEY ALL POLYETHYLENE TIBIAL COMPONENTK932222SLT FEMORAL HEADK932858ORTHOLOC ADVANTIM TIBIAL BASE COMPONENTK930228ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE

View all 74 devices →

Related Devices (Code: GZT)

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.

K252995Durashield Device KitSurGenTec, LLCK210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.K202072MindsEye Expandable PortMinnetronix Neuro, Inc.K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbHK172433NICO BrainPathNico Corporation

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.

↑