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FDA 510(k)

SENSATOUCH

K-Number: K042250 · 2004-11-12

ApplicantAluna Management Co., Ltd.
Decision Date2004-11-12
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SENSATOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Aluna Management Co., Ltd.. It received FDA 510(k) clearance on 2004-11-12 under 510(k) number K042250. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSATOUCH?

SENSATOUCH is a medical device that received FDA 510(k) clearance on 2004-11-12. The listed applicant is Aluna Management Co., Ltd.. The 510(k) number is K042250.

When did SENSATOUCH receive FDA 510(k) clearance?

SENSATOUCH received FDA 510(k) clearance on 2004-11-12, under 510(k) number K042250.

Who is the listed applicant for SENSATOUCH?

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

What is the FDA product code for SENSATOUCH?

The FDA product code for SENSATOUCH is IYO.

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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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