Burn Bath
FDA 510(k) K841397 · Setma, Inc.
510(k) numberK841397
Submission
- Device name
- Burn Bath
- Applicant
- Setma, Inc.
Mchenry, IL, US - Received
- April 3, 1984
- Decision date
- May 18, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K854861 | Setma Hygia Bath Model ST 7200ILJ · Traditional | 01/03/1986SE |
| K854263 | Setma FHT, Model ST 8130ILJ · Traditional | 11/13/1985SE |
| K853163 | Setma VHTILJ · Traditional | 11/05/1985SE |
| K841398 | Variable Height Transfer ChairFSA · Traditional | 05/07/1984SE |
| K841396 | Transfer TrolleyFDA · Traditional | 05/07/1984SE |
| K841395 | Shower TrolleyFSA · Traditional | 05/07/1984SE |
Questions and answers
When was Burn Bath cleared by the FDA?
Burn Bath (K841397) received a 510(k) decision of Substantially Equivalent on May 18, 1984, 45 days after the submission was received.
What is the product code of K841397?
The FDA product code is ILJ – Bath, Hydro-Massage, a Class II (moderate risk) device regulated under 21 CFR 890.5100.