Huntleigh Alphacare, HM95 Alternating Press-Pump
FDA 510(k) K844879 · Huntleigh Technology, Inc.
510(k) numberK844879
Submission
- Device name
- Huntleigh Alphacare, HM95 Alternating Press-Pump
- Applicant
- Huntleigh Technology, Inc.
Aberdeen, NJ, US - Received
- December 17, 1984
- Decision date
- January 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FNM – Mattress, Air Flotation, Alternating Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5550
- Specialty
- General Hospital
Other 510(k)s with product code FNM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973169 | Pressure Guard Site Select (a)FNM · Traditional | Span-America Medical Systems, Inc. | 02/20/1998SE |
| K974319 | Mighty AirFNM · Traditional | Wheelchairs of Kansas | 01/22/1998SE |
| K972022 | ZAK-2000FNM · Traditional | Cardio Systems, Inc. | 01/22/1998SE |
| K974070 | PHYSIO/1000FNM · Traditional | Physio Designs, Inc. | 01/06/1998SE |
| K972549 | SimpulseFNM · Traditional | Kinetic Concepts, Inc. | 11/18/1997SE |
| K970081 | Super Air 9000 Alternating Air Floatation Mattress SystemFNM · Traditional | Cathay Consolidated, Inc. | 11/07/1997SE |
| K955243 | BariairFNM · Traditional | Kinetic Concepts, Inc. | 10/23/1997SE |
| K970468 | KT Air BedFNM · Traditional | Kinetic Concepts, Inc. | 09/05/1997SE |
| K965207 | Rid-Decube IIFNM · Traditional | Skin Care Management, Inc. | 08/21/1997SE |
| K972153 | Alternating Pressure Air Flotation MattressFNM · Traditional | Decubiti Concepts, Inc. | 07/31/1997SE |
More from Decubiti Concepts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992733 | Akron ATP9 Traction MachineITH · Traditional | 11/10/1999SE |
| K964699 | Rheo Dopplex II (RD 2)IYN · Traditional | 02/21/1997SE |
| K924516 | OP3/VP4HGL · Traditional | 06/28/1993SE |
| K910188 | Flowplus AC330 Pump GarmentsJOW · Traditional | 05/28/1991SE |
| K900882 | Multi Dopplex, MD-1JAF · Traditional | 08/22/1990SE |
| K900618 | Huntleigh Fetal Doppler, FD-1 & Dopcord, D140KNG · Traditional | 04/25/1990SE |
| K890012 | Huntleigh Dynamic Flotation SystemFNM · Traditional | 03/29/1989SE |
| K884451 | Dopcord PPGJOM · Traditional | 01/12/1989SE |
| K881632 | Flowtron DVT System AC500 Pump, L501 GarmentJOW · Traditional | 09/26/1988SE |
| K874688 | Flowtron AC200/2IRP · Traditional | 09/23/1988SE |
Questions and answers
When was Huntleigh Alphacare, HM95 Alternating Press-Pump cleared by the FDA?
Huntleigh Alphacare, HM95 Alternating Press-Pump (K844879) received a 510(k) decision of Substantially Equivalent on January 25, 1985, 39 days after the submission was received.
What is the product code of K844879?
The FDA product code is FNM – Mattress, Air Flotation, Alternating Pressure, a Class II (moderate risk) device regulated under 21 CFR 880.5550.