Home Care Bead Bed
FDA 510(k) K972176 · Kinetic Concepts, Inc.
510(k) numberK972176
Submission
- Device name
- Home Care Bead Bed
- Applicant
- Kinetic Concepts, Inc.
San Antonio, TX, US - Received
- June 9, 1997
- Decision date
- January 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- INX – Bed, Air Fluidized
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5160
- Specialty
- Physical Medicine
Other 510(k)s with product code INX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964223 | Clinitron Rite-HiteINX · Traditional | Hill-Rom, Inc. | 05/28/1997SE |
| K943385 | Clinitron ElexisINX · Traditional | Ssi Medical Services, Inc. | 02/27/1995SE |
| K942184 | Clinitron at Home Air Fluided TherapyINX · Traditional | Ssi Medical Services, Inc. | 02/07/1995SE |
| K931168 | X-20 Air Support BedINX · Traditional | American Life Support Technology, Inc. | 02/17/1994SE |
| K934689 | Low Air Loss Mattress, ModificationINX · Traditional | Cardio Systems, Inc. | 02/02/1994SE |
| K924973 | Dylnamedics A.S.A.P.INX · Traditional | Dynamedics, Inc. | 10/15/1993SE |
| K926402 | Comfort Care Low Air Loss Therapy BedINX · Traditional | Ch Administration, Inc. | 03/24/1993SE |
| K924686 | Rem-AirINX · Traditional | Mellenair Ent., Inc. | 02/12/1993SE |
| K920112 | Clinitron C-IiINX · Traditional | Support Systems Intl. | 01/24/1992SE |
| K913654 | Smith and Davis Pressure Therapy SystemINX · Traditional | Smith & Davis Mfg. Co. | 11/22/1991SE |
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| K032310 | Mini V.A.C., V.A.C. Freedom, V.A.C. AtsOMP · Traditional | 10/10/2003SE |
| K022011 | V.A.C. Abdominal DressingFTL · Traditional | 02/26/2003SE |
| K021500 | Vacuum Assisted ClosureOMP · Traditional | 12/20/2002SE |
| K021501 | V.A.C. Instillamat (Vacuum Assisted Closure InstillamatOMP · Traditional | 12/02/2002SE |
| K020781 | Wet ChamberNAD · Traditional | 05/06/2002SE |
| K992448 | V.A.C. PlusOMP · Traditional | 01/18/2000SE |
| K972549 | SimpulseFNM · Traditional | 11/18/1997SE |
| K955243 | BariairFNM · Traditional | 10/23/1997SE |
Questions and answers
When was Home Care Bead Bed cleared by the FDA?
Home Care Bead Bed (K972176) received a 510(k) decision of Substantially Equivalent on January 16, 1998, 221 days after the submission was received.
What is the product code of K972176?
The FDA product code is INX – Bed, Air Fluidized, a Class II (moderate risk) device regulated under 21 CFR 890.5160.