Bath, Hydro-massage
Physical Medicine · 21 CFR 890.5100
Recent MDR events
1,022 adverse event reports on file
- MALIBU/SOVEREIGNJun 1, 2026InjuryArjo Hospital Equipment Ab3007420694-2026-00085
- MALIBU/SOVEREIGNJun 1, 2026InjuryArjo Hospital Equipment Ab1419652-2026-00096
- CONTOUR SPAMar 10, 2026InjuryPenner Patient Care, Inc1922538-2026-00001
- PARKER BATHNov 6, 2025MalfunctionArjo Hospital Equipment Ab3007420694-2025-00271
- APOLLO ADVANTAGE 6000Sep 2, 2025InjuryApollo Corporation22931145
- SYSTEM 2000May 21, 2025MalfunctionArjohuntleigh Polska Sp. Z O.o.3007420694-2025-00128
- SYSTEM 2000May 9, 2025MalfunctionArjohuntleigh Polska Sp. Z O.o.3007420694-2025-00119
- SYSTEM 2000Apr 24, 2025MalfunctionArjohuntleigh Polska Sp. Z O.o.3007420694-2025-00117
- MALIBU/SOVEREIGNMar 26, 2025MalfunctionArjohuntleigh Polska Sp. Z O.o.3007420694-2025-00073
- MALIBU/SOVEREIGNMar 13, 2025MalfunctionArjohuntleigh Polska Sp. Z O.o.3007420694-2025-00069
Event type breakdown
Recalls
10 recall events for this product code
- Penner Patient Care, Inc.Open, ClassifiedMar 9, 2026
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
The device does not bear a unique device identifier.
Z-1499-2026 · View FDA record ↗ - Penner Patient Care, Inc.Open, ClassifiedMar 9, 2026
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 3600
The device does not bear a unique device identifier.
Z-1500-2026 · View FDA record ↗ - Penner Patient Care, Inc.Open, ClassifiedMar 9, 2026
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
The device does not bear a unique device identifier.
Z-1501-2026 · View FDA record ↗ - Penner Patient Care, Inc.Open, ClassifiedMar 9, 2026
Penner Pacific Bathing Spa, Model Numbers 360020-1P
The device does not bear a unique device identifier.
Z-1502-2026 · View FDA record ↗ - Penner Patient Care, Inc.Open, ClassifiedMar 9, 2026
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS,
The device does not bear a unique device identifier.
Z-1503-2026 · View FDA record ↗ - Penner Patient Care, Inc.Open, ClassifiedMar 9, 2026
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I,
The device does not bear a unique device identifier.
Z-1504-2026 · View FDA record ↗ - Penner Patient Care, Inc.Open, ClassifiedMar 9, 2026
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
The device does not bear a unique device identifier.
Z-1505-2026 · View FDA record ↗ - Penner Patient Care, Inc.Open, ClassifiedMar 9, 2026
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
The device does not bear a unique device identifier.
Z-1506-2026 · View FDA record ↗ - Penner Patient Care, Inc.Open, ClassifiedMar 9, 2026
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
The device does not bear a unique device identifier.
Z-1507-2026 · View FDA record ↗ - Penner Patient Care, Inc.Open, ClassifiedMar 9, 2026
Penner Pacific Bathing Spa, Model Numbers 860010-1L
The device does not bear a unique device identifier.
Z-1508-2026 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
Arjohuntleigh Polska Sp. Zo.o.
Poznan Wielkopolskie, PL
Dongguan Jifan Electric Appliance Co., Ltd
Dongguan Guangdong, CN
Shenzhen Margotan Tech Co., Ltd.
shenzhen Guangdong, CN
Since Household Care Co.,ltd
Dongguan City Guangdong, CN
Penner Patient Care, Inc
Aurora, NE, US
Arjo Canada Inc.
Mississauga Ontario, CA
Multi Garmen Indonesia
BOGOR Jawa Barat, ID
510(k) clearances
73 clearances for this product code
- Arjohuntleigh, Inc.Jul 6, 2011
K110994 · PARKER 500
- Arjo Hospital Equipment ABApr 8, 2009
K082951 · IMMERSION HYDROBATH
- Enneking Medical, Inc.Jan 26, 2006
K052479 · MBATH 1000 (60)
- Penner Manufacturing, Inc.Apr 5, 2004
K040772 · PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
- Penner Manufacturing, Inc.Jul 19, 2001
K012061 · SUPERIOR BATH, MODEL 6300
- Penner Manufacturing, Inc.Jul 19, 2001
K012057 · CASCADE BATH, MODEL 6900
- Arjo, Inc.May 1, 2000
K001079 · RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
- Vancare, Inc.Feb 16, 2000
K993872 · VANNA BATHING SYSTEM