FDA 510(k)

TENS DEVICE

K-Number: K813098 · 1981-11-20

Decision Date1981-11-20

Product Code

DecisionSubstantially Equivalent

Device Summary

TENS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Staodynamics, Inc.. It received FDA 510(k) clearance on 1981-11-20 under 510(k) number K813098. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS DEVICE?

TENS DEVICE is a medical device that received FDA 510(k) clearance on 1981-11-20. The listed applicant is Staodynamics, Inc.. The 510(k) number is K813098.

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

TENS DEVICE received FDA 510(k) clearance on 1981-11-20, under 510(k) number K813098.

Who is the listed applicant for TENS DEVICE?

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

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Staodynamics, Inc. as applicant

K852298TENS-AID STERILE ELECTRODES FOR POST-OP TENS K843964TENS-AID PREMIUM ELECTRODES K832988STAODYN EMS/PLUS K81328310D (TENS DEVICE)K811345INSIGHT K792501PLS MINI

View all 14 devices →

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.