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FDA 510(k)

MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY

K-Number: K950681 · 1995-05-16

ApplicantInvacare Corp.
Decision Date1995-05-16
Product CodeIKZ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 1995-05-16 under 510(k) number K950681. 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 MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY?

MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY is a medical device that received FDA 510(k) clearance on 1995-05-16. The listed applicant is Invacare Corp.. The 510(k) number is K950681.

When did MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY receive FDA 510(k) clearance?

MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY received FDA 510(k) clearance on 1995-05-16, under 510(k) number K950681.

Who is the listed applicant for MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY?

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

What is the FDA product code for MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY?

The FDA product code for MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY is IKZ.

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Other records listing Invacare Corp. 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.

K071928THE INVACARE FLYER, MODEL IPC 100K070321TWILIGHT FULL FACE MASKK062402EASYSTAND EVOLVK061874INVACARE'S TWILIGHT II NASAL MASKSK033819INVACARE 3G TARSYSK031176INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000

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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.K962788CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEMGaymar Industries, Inc.K954671THE FREEDOM BEDProbed Medical Technologies, Inc.K950756PULMONEX DYNAMIC AIR THERAPY UNITHill-Rom, Inc.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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