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FDA 510(k)

POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7

K-Number: K071596 · 2008-02-15

Decision Date2008-02-15
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Seimitsu Sokki Co., Ltd.. It received FDA 510(k) clearance on 2008-02-15 under 510(k) number K071596. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7?

POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 is a medical device that received FDA 510(k) clearance on 2008-02-15. The listed applicant is Nihon Seimitsu Sokki Co., Ltd.. The 510(k) number is K071596.

When did POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 receive FDA 510(k) clearance?

POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 received FDA 510(k) clearance on 2008-02-15, under 510(k) number K071596.

Who is the listed applicant for POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7?

The FDA 510(k) record lists Nihon Seimitsu Sokki Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7?

The FDA product code for POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 is IRP.

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 Nihon Seimitsu Sokki Co., 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.

View all 21 devices →

Related Devices (Code: IRP)

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

View on FDA Database →

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

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