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FDA 510(k)

THERACARE LOUNGER

K-Number: K863892 · 1986-10-23

ApplicantAmerican Theracare
Decision Date1986-10-23
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERACARE LOUNGER is the device name listed in this FDA 510(k) record. The listed applicant is American Theracare. It received FDA 510(k) clearance on 1986-10-23 under 510(k) number K863892. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERACARE LOUNGER?

THERACARE LOUNGER is a medical device that received FDA 510(k) clearance on 1986-10-23. The listed applicant is American Theracare. The 510(k) number is K863892.

When did THERACARE LOUNGER receive FDA 510(k) clearance?

THERACARE LOUNGER received FDA 510(k) clearance on 1986-10-23, under 510(k) number K863892.

Who is the listed applicant for THERACARE LOUNGER?

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

What is the FDA product code for THERACARE LOUNGER?

The FDA product code for THERACARE LOUNGER is IOR.

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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.

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