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)

TENSCARE, MODEL TENS XL-2

K-Number: K003591 · 2001-02-14

ApplicantTenscare, Ltd.
Decision Date2001-02-14
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENSCARE, MODEL TENS XL-2 is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2001-02-14 under 510(k) number K003591. 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 TENSCARE, MODEL TENS XL-2?

TENSCARE, MODEL TENS XL-2 is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Tenscare, Ltd.. The 510(k) number is K003591.

When did TENSCARE, MODEL TENS XL-2 receive FDA 510(k) clearance?

TENSCARE, MODEL TENS XL-2 received FDA 510(k) clearance on 2001-02-14, under 510(k) number K003591.

Who is the listed applicant for TENSCARE, MODEL TENS XL-2?

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

What is the FDA product code for TENSCARE, MODEL TENS XL-2?

The FDA product code for TENSCARE, MODEL TENS XL-2 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 Tenscare, 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.

K232441Unipro (K-UNIPRO-US)K230926Ova+ (K-OVAP-USA)K230983Unicare (K-UNICARE-USA)K231053Unicare (K-UNICARE-USA)K200694Perfect EMSK191312Perfect PFE

View all 12 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.

↑