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FDA 510(k)

RELAXY-THE WONDER HAND

K-Number: K950322 · 1995-02-14

ApplicantKinsei Shiatsu, Inc.
Decision Date1995-02-14
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

RELAXY-THE WONDER HAND is the device name listed in this FDA 510(k) record. The listed applicant is Kinsei Shiatsu, Inc.. It received FDA 510(k) clearance on 1995-02-14 under 510(k) number K950322. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the RELAXY-THE WONDER HAND?

RELAXY-THE WONDER HAND is a medical device that received FDA 510(k) clearance on 1995-02-14. The listed applicant is Kinsei Shiatsu, Inc.. The 510(k) number is K950322.

When did RELAXY-THE WONDER HAND receive FDA 510(k) clearance?

RELAXY-THE WONDER HAND received FDA 510(k) clearance on 1995-02-14, under 510(k) number K950322.

Who is the listed applicant for RELAXY-THE WONDER HAND?

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

What is the FDA product code for RELAXY-THE WONDER HAND?

The FDA product code for RELAXY-THE WONDER HAND is ISA.

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 Kinsei Shiatsu, 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.

K952990SPIN ROLLEREK952916SHIATSU MASTER MASSAGER CUSHIONK950411RELAXU-1K950321SHAPE UP MOMI ROLLERK950320RELAXY-WONDER KNOCK

Related Devices (Code: ISA)

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.

K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave TrtK220538DolorClast RadialE.M.S Electro Medical Systems S.A

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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