Panels › General Hospital › Product code IKY · Class 1
Mattress, Flotation Therapy, Non-Powered
Regulation 880.5150
0510(k)s in 12 months (8 all time)
0recalls in 12 months (11 all time)
0recalls that name a 510(k)
Top companies in IKY
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Medical Division of Stryker Corporation | 0 | 5 |
| EHOB, Inc. | 0 | 2 |
| Jefferson Industries, Inc. | 2 | 0 |
| Joerns Healthcare | 0 | 2 |
| Medpro, Inc. | 2 | 0 |
| Arco Medical Products Co. | 1 | 0 |
| Arjo Hospital Equipment AB | 0 | 1 |
| Gaymar Industries, Inc. | 1 | 0 |
| KCI USA, Inc. | 0 | 1 |
| Leemart Bedding Mfg. Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2021 | Stryker Medical Division of Stryker Corporation IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999 Open, Classified |
IKY | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009 Open, Classified |
IKY | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #2710000027 Open, Classified |
IKY | None listed |
| Apr 19, 2021 | EHOB, Inc. Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort.
Product Code: 1025ECP Open, Classified |
IKY | None listed |
| Aug 12, 2020 | Stryker Medical Division of Stryker Corporation Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100 Terminated |
IKY | None listed |
| Jan 19, 2020 | EHOB, Inc. Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line o Terminated |
IKY | None listed |
| May 3, 2018 | Joerns Healthcare ProCair Mattress:
(a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280
(b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680
(c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384
Product Usage:
Non powered Terminated |
IKY | None listed |
| May 3, 2018 | Joerns Healthcare P.R.O. Matt:
(a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA
(b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA
(c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMB Terminated |
IKY | None listed |
| Mar 6, 2015 | Arjo Hospital Equipment AB Pressure IQ Evolve Mattress; Non-powered mattress replacement system.
Intended for patients with medium to high risk for developing pressure ulcers while on a mattress. Terminated |
IKY | None listed |
| May 23, 2011 | Stryker Medical Division of Stryker Corporation Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI.
The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for Terminated |
IKY | None listed |
| Jan 25, 2010 | KCI USA, Inc. AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268840 used with First Step All-In-One Canadian French Models 227500-09 and 227500, First Step Terminated |
IKY | None listed |
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