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FDA 510(k)

NEXT WAVE PHYSIOACOUSTIC MATTRESS

K-Number: K934886 · 1994-06-09

Decision Date1994-06-09
Product CodeIRO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

NEXT WAVE PHYSIOACOUSTIC MATTRESS is the device name listed in this FDA 510(k) record. The listed applicant is Next Wave, Inc.. It received FDA 510(k) clearance on 1994-06-09 under 510(k) number K934886. The device is classified under product code IRO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NEXT WAVE PHYSIOACOUSTIC MATTRESS?

NEXT WAVE PHYSIOACOUSTIC MATTRESS is a medical device that received FDA 510(k) clearance on 1994-06-09. The listed applicant is Next Wave, Inc.. The 510(k) number is K934886.

When did NEXT WAVE PHYSIOACOUSTIC MATTRESS receive FDA 510(k) clearance?

NEXT WAVE PHYSIOACOUSTIC MATTRESS received FDA 510(k) clearance on 1994-06-09, under 510(k) number K934886.

Who is the listed applicant for NEXT WAVE PHYSIOACOUSTIC MATTRESS?

The FDA 510(k) record lists Next Wave, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEXT WAVE PHYSIOACOUSTIC MATTRESS?

The FDA product code for NEXT WAVE PHYSIOACOUSTIC MATTRESS is IRO.

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 Next Wave, 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: IRO)

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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