510(k) K911246
- Device
- The Mediscus Pedcare Management System-model 2
- Applicant
- THE MEDICAL GROUP, INC.
- 510(k) number
- K911246
- Product code
- INX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-06-06
- Date received
- 1991-03-21
- Regulation
- 890.5160
- Classification name
- Bed, Air Fluidized
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HELEN RAEEFSEMO
- Address
- P.O. Box 5067 Buena Park CA US 90620 90620
FDA Registration Numbers#
- 3005529226
- 9611484
- 3007420694
- 3018070887
- 3014650138
- 1824206
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code INX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972176 | HOME CARE BEAD BED | Kinetic Concepts, Inc. | 1998-01-16 |
| K964223 | CLINITRON RITE-HITE | Hill-Rom, Inc. | 1997-05-28 |
| K943385 | CLINITRON ELEXIS | Ssi Medical Services, Inc. | 1995-02-27 |
| K942184 | CLINITRON AT HOME AIR FLUIDED THERAPY | Ssi Medical Services, Inc. | 1995-02-07 |
| K931168 | X-20 AIR SUPPORT BED | American Life Support Technology, Inc. | 1994-02-17 |
| K934689 | LOW AIR LOSS MATTRESS, MODIFICATION | Cardio Systems, Inc. | 1994-02-02 |
| K924973 | DYLNAMEDICS A.S.A.P. | Dynamedics, Inc. | 1993-10-15 |
| K926402 | COMFORT CARE LOW AIR LOSS THERAPY BED | Ch Administration, Inc. | 1993-03-24 |
| K924686 | REM-AIR | Mellenair Ent., Inc. | 1993-02-12 |
| K920112 | CLINITRON C-II | Support Systems Intl. | 1992-01-24 |
| K913654 | SMITH AND DAVIS PRESSURE THERAPY SYSTEM | Smith & Davis Mfg. Co. | 1991-11-22 |
| K911057 | DERMATEK 4000 | Anacom General Corp. | 1991-04-05 |
| K904008 | STAGE IV, AIR-FLUIDIZE BED | Unique Flotation Systems, Inc. | 1990-10-10 |
| K890523 | SUPERCAIR | Ssi Medical Services, Inc. | 1989-02-10 |
| K884835 | TASSI MK2 | Therapy Air Support Systems, Inc. | 1988-12-07 |