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FDA 510(k)

SPIN ROLLERE

K-Number: K952990 · 1995-09-29

Decision Date1995-09-29
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

SPIN ROLLERE 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 1995-09-29 under 510(k) number K952990. 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 SPIN ROLLERE?

SPIN ROLLERE is a medical device that received FDA 510(k) clearance on 1995-09-29. The listed applicant is Kinsei Shiatsu, Inc.. The 510(k) number is K952990.

When did SPIN ROLLERE receive FDA 510(k) clearance?

SPIN ROLLERE received FDA 510(k) clearance on 1995-09-29, under 510(k) number K952990.

Who is the listed applicant for SPIN ROLLERE?

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 SPIN ROLLERE?

The FDA product code for SPIN ROLLERE 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.

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.

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.

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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