Chair, Adjustable, Mechanical(INN)
調節式椅子(機械式) この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。
23 件
直近 2026.03.18
26 件
0 件
585 件
分類情報
| Product Code | INN |
|---|---|
| デバイス名 | Chair, Adjustable, Mechanical 調節式椅子(機械式) この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。 |
| デバイスクラス | クラス I |
| 21 CFR 規制番号 | 890.3100 |
| 審査区分 | 届出免除(510(k) Exempt) |
| 医療専門分野 | 理学療法 |
| 定義 | - |
| フラグ | 該当なし |
| AI分析 | 本機器は米国FDA規制においてクラスIに分類される医療機器です。クラスIは一般管理のみで安全性・有効性が確保できると判断される機器であり、本品は市販前届出(510(k))が免除されています。医療専門分野としては理学療法(Physical Medicine)領域に位置づけられています。 米国市場での動向 510(k)の累計件数は約30件、参入企業数は約20社で、直近5年間の届出はありません。不具合報告(MDR)は累計約580件あり、その大半が不具合(Malfunction)として報告されていますが、死亡10件、傷害約140件も含まれています。主な問題としてはMechanical Problem(機械的問題)、Mechanical Jam(機械的な引っかかり)、Material Fragmentation(材料の破断)が挙げられています。回収は累計約20件で、すべてクラスII(中程度)に分類され、直近5年では3件、最新の回収は2026年1月に開始されています。 この分析は公開データ(openFDA・JMDN 対応情報)をもとに AI が生成した参考情報です。市場データは2026年8月時点の集計に基づきます。 |
関連 product code
同じ 21 CFR 890.3100 に分類される product code(1 件)
| No. | product code | 機器名 | クラス | 専門分野 | 510(k) | PMA | 不具合 | 回収 |
|---|---|---|---|---|---|---|---|---|
| 1 | INM | Chair, With Casters キャスター付き椅子 | I | 理学療法 | 35 | — | 3,241 | 25 件 |
機器名の日本語訳は AI により自動生成したものです。正確には英語原文をご確認ください。
FDA のデバイスクラスは 3 段階(クラス I〜III)、日本の医療機器は 4 段階(クラス I〜IV)で分類されており、 1 対 1 では対応しません。 リスク区分の考え方が異なるため、参考情報としてご利用ください。
米国での回収・承認・不具合報告
米国回収
全 23 件| 回収番号 | クラス | 回収開始日 | 企業 | 理由 | ステータス |
|---|---|---|---|---|---|
| Z-1498-2026 INN | クラス II | 2026.01.05 | Raz Design Inc | Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place. | 対応中 |
| Z-0880-2023 INN | クラス II | 2022.11.30 | Altimate Medical, Inc. | Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position. | 終了 |
| Z-0569-2022 INN | クラス II | 2021.12.08 | R82 A/S | The chrome surface of the push brace can crack during use, potentially cutting the user. | 終了 |
| Z-2209-2021 INN | クラス II | 2021.05.12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | 対応中 |
| Z-2403-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2402-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2401-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2400-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2399-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2398-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2397-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2396-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2395-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2394-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2393-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2392-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2391-2015 INN | クラス II | 2015.04.02 | Winco Mfg., LLC | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. | 終了 |
| Z-2023-2014 INN | クラス II | 2014.06.25 | Invacare Corporation | The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame. | 終了 |
| Z-0167-2014 INN | クラス II | 2013.08.31 | Invacare Corporation | The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N, when the product is used in a reclined position and or tilted position. This may result in the snap-on fixture coming unlatched. | 終了 |
| Z-1807-2013 INN | クラス II | 2013.05.23 | Etac Supply Center Ab | Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Swift Mobil shower chair loses a caster and thus becomes instantly unstable, there is potiential risk for harm or injury. | 終了 |
510(k)(市販前届出)
全 26 件| No. | 番号 | 機器名 | 申請者 | 決定日 | 種別 | 概要 |
|---|---|---|---|---|---|---|
| 1 | K945650 | SPIFFY | Thames Valley Children'S Centre | 1994.12.19 | 通常(Traditional) | - |
| 2 | K942397 | THERADAPT HIGHCHAIR/STROLLER INSERT | Theradapt Products, Inc. | 1994.06.22 | 通常(Traditional) | - |
| 3 | K930520 | THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR | Theradapt Products, Inc. | 1993.03.24 | 通常(Traditional) | - |
| 4 | K923753 | ABLE GENERATION THERAPY TILT BENCH | The Able Generation, Inc. | 1993.01.29 | 通常(Traditional) | - |
| 5 | K923752 | ABLE GENERATION PLAY CHAIR | The Able Generation, Inc. | 1993.01.29 | 通常(Traditional) | - |
| 6 | K923750 | ABLE GENERATION BOOSTER CHAIR | The Able Generation, Inc. | 1993.01.29 | 通常(Traditional) | - |
| 7 | K923095 | KAYE MODEL KIAO PELVIC/THIGH STABILIZER | Kaye Products, Inc. | 1992.07.21 | 通常(Traditional) | - |
| 8 | K922061 | CHAIR, ADJUSTABLE, MECHANICAL | Kaye Products, Inc. | 1992.05.26 | 通常(Traditional) | - |
| 9 | K921272 | ACTIVITY CHAIR | Rifton Equipment For the Handicapped | 1992.04.07 | 通常(Traditional) | - |
| 10 | K904069 | BRODA NURSING CARE CHAIR | Broda Ent., Inc. | 1990.09.17 | 通常(Traditional) | - |
| 11 | K902951 | SHOWER-A-WAY | Tri-S-Sales and Mfg. | 1990.07.25 | 通常(Traditional) | - |
| 12 | K902600 | THE COMPANION NON-ELECTRIC LIFT CHAIR | Innovative Medical Engineering, Inc. | 1990.06.21 | 通常(Traditional) | - |
| 13 | K896814 | TOI-LIFT | Mill-Tech Ent., Inc. | 1990.02.20 | 通常(Traditional) | - |
| 14 | K894767 | CORNER SEAT | Canadian Posture and Seating Centre, Inc. | 1990.01.17 | 通常(Traditional) | - |
| 15 | K882090 | HIP SAVER | Pride Health Care, Inc. | 1988.05.26 | 通常(Traditional) | - |
| 16 | K874060 | CONVERTA-LITTER | Camtec | 1987.12.10 | 通常(Traditional) | - |
| 17 | K862957 | MERIVAARA GERIATRIC CHAIR MODEL 455 | Global Medical Prods, Inc. | 1986.08.21 | 通常(Traditional) | - |
| 18 | K862885 | CAR SEAT | Mednet, Inc. | 1986.08.14 | 通常(Traditional) | - |
| 19 | K862883 | ORTHOPEDIC SEATS | Mednet, Inc. | 1986.08.14 | 通常(Traditional) | - |
| 20 | K841691 | SPLIT SEAT POSITIONING CHAIR | Maddak, Inc. | 1984.05.09 | 通常(Traditional) | - |
出典の openFDA は各 510(k) の主要(primary)product code のみを収録しているため、副次コードを含む FDA 公式データベースの検索結果とは件数が異なる場合があります。 FDA 510(k) データベースで確認
PMA(市販前承認)
この product code の PMA 情報はありません。
不具合報告(MAUDE)トレンド
米国不具合報告検索で詳しく見る出典: openFDA(U.S. FDA) のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
各データセット(510(k)・PMA・MAUDE・回収・Warning Letter)の解説は 米国FDA情報の概要 を参照してください。
出典: openFDA(U.S. FDA) のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
取得日: 2026.09.07
各データセット(510(k)・PMA・MAUDE・回収・Warning Letter)の解説は 米国FDA情報の概要 を参照してください。