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FDA 510(k)

SKYLARK MODEL 1001 TENS DEVICE

K-Number: K853898 · 1986-06-18

ApplicantPeleg Intl. Co.
Decision Date1986-06-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SKYLARK MODEL 1001 TENS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Peleg Intl. Co.. It received FDA 510(k) clearance on 1986-06-18 under 510(k) number K853898. 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 SKYLARK MODEL 1001 TENS DEVICE?

SKYLARK MODEL 1001 TENS DEVICE is a medical device that received FDA 510(k) clearance on 1986-06-18. The listed applicant is Peleg Intl. Co.. The 510(k) number is K853898.

When did SKYLARK MODEL 1001 TENS DEVICE receive FDA 510(k) clearance?

SKYLARK MODEL 1001 TENS DEVICE received FDA 510(k) clearance on 1986-06-18, under 510(k) number K853898.

Who is the listed applicant for SKYLARK MODEL 1001 TENS DEVICE?

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

What is the FDA product code for SKYLARK MODEL 1001 TENS DEVICE?

The FDA product code for SKYLARK MODEL 1001 TENS DEVICE 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 Peleg Intl. Co. 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.

K861214SKYLARK GB 1000

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.

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