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FDA 510(k)

CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM

K-Number: K962788 · 1997-04-30

ApplicantGaymar Industries, Inc.
Decision Date1997-04-30
Product CodeIKZ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gaymar Industries, Inc.. It received FDA 510(k) clearance on 1997-04-30 under 510(k) number K962788. The device is classified under product code IKZ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM?

CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-30. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K962788.

When did CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM receive FDA 510(k) clearance?

CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM received FDA 510(k) clearance on 1997-04-30, under 510(k) number K962788.

Who is the listed applicant for CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM?

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

What is the FDA product code for CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM?

The FDA product code for CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM is IKZ.

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Other records listing Gaymar Industries, 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.

K100585MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPK963067SOF. PRESS EPC 51 SYSTEMK961854SPR PLUS II OVERLAY SYSTEM (CL250/CL212K942881TC 3000K930345TC2000 POWER UNIT AND ACCESSORIES

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Related Devices (Code: IKZ)

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.

K972486PRESSUREGUARD IVSpan-America Medical Systems, Inc.K972111RUMORS DYNAMIC AIR THERAPY UNITHill-Rom, Inc.K954671THE FREEDOM BEDProbed Medical Technologies, Inc.K950756PULMONEX DYNAMIC AIR THERAPY UNITHill-Rom, Inc.K950681MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPYInvacare Corp.K933964THE CRADLEThe Primal Energy Research Foundation

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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