Vichy Shower
FDA 510(k) K980909 · Bouvier Hydro, Inc.
510(k) numberK980909
Submission
- Device name
- Vichy Shower
- Applicant
- Bouvier Hydro, Inc.
Champlain,, NY, US - Received
- March 10, 1998
- Decision date
- August 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ILJ – Bath, Hydro-Massage
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5100
- Specialty
- Physical Medicine
Other 510(k)s with product code ILJ
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|---|---|---|---|
| K110994 | Parker 500ILJ · Abbreviated | Arjohuntleigh, Inc. | 07/06/2011SE |
| K082951 | Immersion HydrobathILJ · Traditional | Arjo Hospital Equipment AB | 04/08/2009SE |
| K052479 | Mbath 1000 (60)ILJ · Traditional | Enneking Medical, Inc. | 01/26/2006SE |
| K040772 | Pacific Recumbent Height-Adjustable Bath SystemILJ · Traditional | Penner Manufacturing, Inc. | 04/05/2004SE |
| K012061 | Superior Bath, Model 6300ILJ · Traditional | Penner Manufacturing, Inc. | 07/19/2001SE |
| K012057 | Cascade Bath, Model 6900ILJ · Traditional | Penner Manufacturing, Inc. | 07/19/2001SE |
| K001079 | Recumbent Bathing Systems, Rhapsody and PrimoILJ · Traditional | Arjo, Inc. | 05/01/2000SE |
| K993872 | Vanna Bathing SystemILJ · Traditional | Vancare, Inc. | 02/16/2000SE |
| K992779 | A-2000 Bathing Systems; Hydrosonic Bathin SystemILJ · Traditional | Medi-Man Rehabilitation Products, Inc. | 01/13/2000SE |
| K991184 | Hydrotone-Thermal Capsule SystemILJ · Abbreviated | Nats Corp. | 06/23/1999SE |
More from Nats Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K980920 | EquinoxeILJ · Traditional | 07/16/1998SE |
Questions and answers
When was Vichy Shower cleared by the FDA?
Vichy Shower (K980909) received a 510(k) decision of Substantially Equivalent on August 11, 1998, 154 days after the submission was received.
What is the product code of K980909?
The FDA product code is ILJ – Bath, Hydro-Massage, a Class II (moderate risk) device regulated under 21 CFR 890.5100.