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FDA 510(k)

RELAXPLUS

K-Number: K951213 · 1995-09-20

ApplicantUltramind International , Ltd.
Decision Date1995-09-20
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RELAXPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Ultramind International , Ltd.. It received FDA 510(k) clearance on 1995-09-20 under 510(k) number K951213. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELAXPLUS?

RELAXPLUS is a medical device that received FDA 510(k) clearance on 1995-09-20. The listed applicant is Ultramind International , Ltd.. The 510(k) number is K951213.

When did RELAXPLUS receive FDA 510(k) clearance?

RELAXPLUS received FDA 510(k) clearance on 1995-09-20, under 510(k) number K951213.

Who is the listed applicant for RELAXPLUS?

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

What is the FDA product code for RELAXPLUS?

The FDA product code for RELAXPLUS is HCC.

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 Ultramind International , 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.

K980373ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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