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)

PULSAR #B SINGLE CHANNEL TENS-PULSAR D

K-Number: K831950 · 1983-08-01

ApplicantSpembly Medical , Ltd.
Decision Date1983-08-01
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PULSAR #B SINGLE CHANNEL TENS-PULSAR D is the device name listed in this FDA 510(k) record. The listed applicant is Spembly Medical , Ltd.. It received FDA 510(k) clearance on 1983-08-01 under 510(k) number K831950. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSAR #B SINGLE CHANNEL TENS-PULSAR D?

PULSAR #B SINGLE CHANNEL TENS-PULSAR D is a medical device that received FDA 510(k) clearance on 1983-08-01. The listed applicant is Spembly Medical , Ltd.. The 510(k) number is K831950.

When did PULSAR #B SINGLE CHANNEL TENS-PULSAR D receive FDA 510(k) clearance?

PULSAR #B SINGLE CHANNEL TENS-PULSAR D received FDA 510(k) clearance on 1983-08-01, under 510(k) number K831950.

Who is the listed applicant for PULSAR #B SINGLE CHANNEL TENS-PULSAR D?

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

What is the FDA product code for PULSAR #B SINGLE CHANNEL TENS-PULSAR D?

The FDA product code for PULSAR #B SINGLE CHANNEL TENS-PULSAR D is GZJ.

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 Spembly Medical , Ltd. 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.

K925129SELECTORK903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESK901974SELECTOR ULTRASONIC SURGICAL ASPIRATORK882568130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAYK882962SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)K882963SPEMBLY MEDICAL 142 CRYO UNIT

View all 17 devices →

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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.

↑