Panels › Physical Medicine › Product code ILJ · Class 2
Bath, Hydro-Massage
Regulation 890.5100
0510(k)s in 12 months (73 all time)
10recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in ILJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Penner Patient Care, Inc. | 0 | 10 |
| Dazey Products Co. | 6 | 0 |
| Arjo-Century, Inc. | 4 | 0 |
| Setma, Inc. | 4 | 0 |
| Century Manufacturing Co. | 3 | 0 |
| Heddernheimer Metallwarenfabrik GmbH | 3 | 0 |
| Penner Manufacturing, Inc. | 3 | 0 |
| Aquaciser, Inc. | 2 | 0 |
| Aquatherapy Systems, Inc. | 2 | 0 |
| Associated Mills, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2026 | Penner Patient Care, Inc. Penner Pacific Bathing Spa, Model Numbers 860010-1L Open, Classified |
ILJ | K040772 |
| Mar 9, 2026 | Penner Patient Care, Inc. Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 Open, Classified |
ILJ | K040772 |
| Mar 9, 2026 | Penner Patient Care, Inc. Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL Open, Classified |
ILJ | K040772 |
| Mar 9, 2026 | Penner Patient Care, Inc. Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 Open, Classified |
ILJ | K040772 |
| Mar 9, 2026 | Penner Patient Care, Inc. Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I,
361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X Open, Classified |
ILJ | K040772 |
| Mar 9, 2026 | Penner Patient Care, Inc. 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, 360030-XCTS, 3600301-CTS, 360030-XCE, 36 Open, Classified |
ILJ | K040772 |
| Mar 9, 2026 | Penner Patient Care, Inc. Penner Pacific Bathing Spa, Model Numbers 360020-1P Open, Classified |
ILJ | K040772 |
| Mar 9, 2026 | Penner Patient Care, Inc. Penner Pacific Bathing Spa, Model Numbers 360020-1EP Open, Classified |
ILJ | K040772 |
| Mar 9, 2026 | Penner Patient Care, Inc. 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, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W Open, Classified |
ILJ | K040772 |
| Mar 9, 2026 | Penner Patient Care, Inc. Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X Open, Classified |
ILJ | K040772 |
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