Home › Device types › IKY
Mattress, Flotation Therapy, Non-Powered
FDA product code IKY · Class 1 · General Hospital
2,055
Registered devices
1,569
Adverse events
11
Recalls
8
510(k) clearances
Devices with this code
C-MATT — CASCO MANUFACTURING SOLUTIONS, INC.C-MATT — CASCO MANUFACTURING SOLUTIONS, INC.C-MATT — CASCO MANUFACTURING SOLUTIONS, INC.GeoMattress — SPAN-AMERICA MEDICAL SYSTEMS, INC.Span-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.Span-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.Repose Mattress Overlay — Frontier Therapeutics IncC-MATT — CASCO MANUFACTURING SOLUTIONS, INC.Drive — Drive Devilbiss HealthcareSpan-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.Span-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.Span-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.Ergozone 3000 — L I N E T spol. s r.o.STR MAT-5X26X76-2T-STATIC AIR-CAL117-PC — CURBELL MEDICAL PRODUCTS, INC.C-MATT — CASCO MANUFACTURING SOLUTIONS, INC.C-MATT — CASCO MANUFACTURING SOLUTIONS, INC.C-MATT — CASCO MANUFACTURING SOLUTIONS, INC.C-MATT — CASCO MANUFACTURING SOLUTIONS, INC.Span-America — SPAN-AMERICA MEDICAL SYSTEMS, INC.Accumax Surface — HILL-ROM, INC.ThevoCalm FR 308 lbs, Full size 54x75", jersey white — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftInvacare Essentials — INVACARE CORPORATIONInvacare Solace Mattress — INVACARE CORPORATIONC-MATT — CASCO MANUFACTURING SOLUTIONS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labe |
| 2021-05-12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labe |
| 2021-05-12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labe |
| 2021-04-19 | EHOB, Inc. | Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates |
| 2020-08-12 | Stryker Medical Division of Stryker Corporation | Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation effort |
| 2020-01-19 | EHOB, Inc. | Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subse |
| 2018-05-03 | Joerns Healthcare | Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt a |
| 2018-05-03 | Joerns Healthcare | Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt a |
| 2014-09-01 | Arjo Hospital Equipment AB | The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers. |
| 2011-04-29 | Stryker Medical Division of Stryker Corporation | Affected mattresses may not conform to federal flammability standards. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.