FDA 510(k)

THERMAL MASSAGE BED, MODEL 2D-GX

K-Number: K102281 · 2010-12-22

Decision Date2010-12-22

Product CodeJFB

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

THERMAL MASSAGE BED, MODEL 2D-GX is the device name listed in this FDA 510(k) record. The listed applicant is Inarex Corporation. It received FDA 510(k) clearance on 2010-12-22 under 510(k) number K102281. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMAL MASSAGE BED, MODEL 2D-GX?

THERMAL MASSAGE BED, MODEL 2D-GX is a medical device that received FDA 510(k) clearance on 2010-12-22. The listed applicant is Inarex Corporation. The 510(k) number is K102281.

When did THERMAL MASSAGE BED, MODEL 2D-GX receive FDA 510(k) clearance?

THERMAL MASSAGE BED, MODEL 2D-GX received FDA 510(k) clearance on 2010-12-22, under 510(k) number K102281.

Who is the listed applicant for THERMAL MASSAGE BED, MODEL 2D-GX?

The FDA 510(k) record lists Inarex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMAL MASSAGE BED, MODEL 2D-GX?

The FDA product code for THERMAL MASSAGE BED, MODEL 2D-GX is JFB.

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Other records listing Inarex Corporation as applicant

K080554INAREX, MODEL 2D-LX

Related Devices (Code: JFB)

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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.