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Life Design Systems, Inc.

United StatesFDA applicant, unverified

Devices
29

What Life Design Systems, Inc. makes

Life Design Systems, Inc. makes medical devices such as headstraps, face masks, and resuscitators, including the Pulmanex and Cushion-Flex models. They also produce flow generators for sleep apnea, pulmonary assist devices, and valves for respiratory care. Their products include the FLEX-CUP Percussor and the CARHILL one-way resuscitation valve. The company's devices are used in various medical applications, including respiratory therapy and sleep apnea treatment.

The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA 510(k) registry. Life Design Systems, Inc. is based in the US.

AI-generated from registry data, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue29

Newest first, rows 1-29 of 29

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  • Headstrap Ref K854537

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Modified Cushion-Flex(Tm) Ref K890108

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Modification Manual Pulmon Resuscitor/Pulmanex(Tm) Ref K913714

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Flow Generator For Sleep Apnea, Lds 1500 Ref K862448

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pulmanex Ref K854037

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cushion Flex(Tm) Ref K884387

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Filter-Flex Ref K841236

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cushion-Flex Tm-Cpap Face Mask Ref K854458

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Babyset Tm & Pac Tm -Pulmonary Assist Ref K841264

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Flex-Cup Percussor Ref K892862

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lds Peep Valve Ref K854822

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Carhill One-Way Resuscitation Valve Ref K864681

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oxygen Connector And Oxygen Delivery Tubing Ref K890011

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Pulmanex Tm (Modification) Ref K863026

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pulmanex (Tm) Ref K860693

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lds Monitoring Electrode Ref K821846

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Babyset(Tm) Modified Jackson-Rees Circuit W/Valve Ref K871669

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Resuscitator, Pulmonary, Manual Ref K844729

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Anesthesia Breathing Circuit Ref K821087

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cushion-Flex Tm Ref K843169

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Pulse-Ox Ref K863857

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cushion-Flex Tm Nasal Cpap Mask For Sleep Apnea Ref K861758

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pulmanex Tm (Neo-Natal Size) Ref K884068

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Anesthesia Breathing Bag, Various Sizes Ref K822116

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Pulmonary Resuscitator, Modification Ref K892221

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Child Size - Filter Flex (Tm) Ref K893030

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Humidi-Flex Tm Ref K885313

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Heater Wire Breathing Circuit Ref K873179

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • End Tidal CO2 Sampling Circuit Ref K860659

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-29 of 29

Frequently asked questions

How many devices does Life Design Systems, Inc. have in the registry?

The registry currently lists 29 devices for Life Design Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Life Design Systems, Inc.'s devices?

Among its 29 most recently registered devices, Life Design Systems, Inc. has devices listed in FDA 510(k) (29 devices).

What risk classes do Life Design Systems, Inc.'s devices fall under?

Among its 29 most recently registered devices, the classes recorded for Life Design Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Life Design Systems, Inc. in the registry?

The most recently registered devices listed for Life Design Systems, Inc. include HEADSTRAP, MODIFIED CUSHION-FLEX(TM), MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) and FLOW GENERATOR FOR SLEEP APNEA, LDS 1500.

Generated automatically from registry data and not verified by a human reviewer.