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FDA 510(k)

TENS-IT, FITTRONIC II, (MORE LATER)

K-Number: K946018 · 1995-11-09

ApplicantEms, Inc.
Decision Date1995-11-09
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS-IT, FITTRONIC II, (MORE LATER) is the device name listed in this FDA 510(k) record. The listed applicant is Ems, Inc.. It received FDA 510(k) clearance on 1995-11-09 under 510(k) number K946018. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS-IT, FITTRONIC II, (MORE LATER)?

TENS-IT, FITTRONIC II, (MORE LATER) is a medical device that received FDA 510(k) clearance on 1995-11-09. The listed applicant is Ems, Inc.. The 510(k) number is K946018.

When did TENS-IT, FITTRONIC II, (MORE LATER) receive FDA 510(k) clearance?

TENS-IT, FITTRONIC II, (MORE LATER) received FDA 510(k) clearance on 1995-11-09, under 510(k) number K946018.

Who is the listed applicant for TENS-IT, FITTRONIC II, (MORE LATER)?

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

What is the FDA product code for TENS-IT, FITTRONIC II, (MORE LATER)?

The FDA product code for TENS-IT, FITTRONIC II, (MORE LATER) is GZL.

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.

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Other records listing Ems, Inc. 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.

K942428CMT-1000

Related Devices (Code: GZL)

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.

K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); DeptBeijing Sinovation Medical Technology Co., Ltd.K250601Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering , Ltd.K223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument CorporationK223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument CorporationK213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.

Official Source

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