Company ยท US
Joerns Healthcare
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 1997. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 3, 1997 | K964926 | BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC Joerns Healthcare, Inc. | ILJ |
| Aug 18, 1995 | K951735 | JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL Joerns Healthcare, Inc. | FNL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Oct 30, 2014 | Joerns Healthcare Joerns EasyCare Bed
Product Usage:
The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operate Terminated |
FNL | K951735 |
| Apr 7, 2007 | Joerns Healthcare Inc. Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc. Terminated |
FSA | None listed |
| May 25, 2006 | Joerns Healthcare Inc. Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-HLA-2, HML-400, C-HLA-2T and C-HLA-1. Distributed by Sunrise Medical, Inc. 7477 East Dry Creek Parkway, Longmont, CO 80503 USA. Terminated |
FSA | None listed |