Supercair
FDA 510(k) K890523 · Ssi Medical Services, Inc.
510(k) numberK890523
Submission
- Device name
- Supercair
- Applicant
- Ssi Medical Services, Inc.
Chicago, IL, US - Received
- February 2, 1989
- Decision date
- February 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K972176 | Home Care Bead BedINX · Traditional | Kinetic Concepts, Inc. | 01/16/1998SE |
| 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 |
More from Support Systems Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K943385 | Clinitron ElexisINX · Traditional | 02/27/1995SE |
| K942184 | Clinitron at Home Air Fluided TherapyINX · Traditional | 02/07/1995SE |
| K914351 | Clinitron C-10IXQ · Traditional | 02/14/1992SE |
| K882161 | Acucair Cushion Continuous Airflow SystemFNM · Traditional | 07/12/1988SE |
| K863047 | FlexicairIOQ · Traditional | 09/05/1986SE |
Questions and answers
When was Supercair cleared by the FDA?
Supercair (K890523) received a 510(k) decision of Substantially Equivalent on February 10, 1989, 8 days after the submission was received.
What is the product code of K890523?
The FDA product code is INX – Bed, Air Fluidized, a Class II (moderate risk) device regulated under 21 CFR 890.5160.