Clinitron at Home Air Fluided Therapy

FDA 510(k) K942184 · Ssi Medical Services, Inc.

Substantially Equivalent

510(k) numberK942184

Submission

Device name
Clinitron at Home Air Fluided Therapy
Applicant
Ssi Medical Services, Inc.
Charleston, SC, US
Received
May 4, 1994
Decision date
February 7, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K972176Home Care Bead BedINX · Traditional Kinetic Concepts, Inc.01/16/1998SE
K964223Clinitron Rite-HiteINX · Traditional Hill-Rom, Inc.05/28/1997SE
K943385Clinitron ElexisINX · Traditional Ssi Medical Services, Inc.02/27/1995SE
K931168X-20 Air Support BedINX · Traditional American Life Support Technology, Inc.02/17/1994SE
K934689Low Air Loss Mattress, ModificationINX · Traditional Cardio Systems, Inc.02/02/1994SE
K924973Dylnamedics A.S.A.P.INX · Traditional Dynamedics, Inc.10/15/1993SE
K926402Comfort Care Low Air Loss Therapy BedINX · Traditional Ch Administration, Inc.03/24/1993SE
K924686Rem-AirINX · Traditional Mellenair Ent., Inc.02/12/1993SE
K920112Clinitron C-IiINX · Traditional Support Systems Intl.01/24/1992SE
K913654Smith and Davis Pressure Therapy SystemINX · Traditional Smith & Davis Mfg. Co.11/22/1991SE

More from Smith & Davis Mfg. Co.

510(k)DeviceDecision
K943385Clinitron ElexisINX · Traditional 02/27/1995SE
K914351Clinitron C-10IXQ · Traditional 02/14/1992SE
K890523SupercairINX · Traditional 02/10/1989SE
K882161Acucair Cushion Continuous Airflow SystemFNM · Traditional 07/12/1988SE
K863047FlexicairIOQ · Traditional 09/05/1986SE

Questions and answers

When was Clinitron at Home Air Fluided Therapy cleared by the FDA?

Clinitron at Home Air Fluided Therapy (K942184) received a 510(k) decision of Substantially Equivalent on February 7, 1995, 279 days after the submission was received.

What is the product code of K942184?

The FDA product code is INX – Bed, Air Fluidized, a Class II (moderate risk) device regulated under 21 CFR 890.5160.