FDA Device Registration & Listing · Perris, CA, US · Registration 3043460907
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KMN | Chair And Table, Medical | General Hospital | Class 1 | 880.6140 | 2001-05-09 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2025-07-25 |
| IPS | Cane | Physical Medicine | Class 1 | 890.3075 | 2003-11-12 |
| IPR | Crutch | Physical Medicine | Class 1 | 890.3150 | 2003-11-12 |
| ILS | Adaptor, Hygiene | Physical Medicine | Class 1 | 890.5050 | 2002-10-15 |
| IOR | Wheelchair, Mechanical | Physical Medicine | Class 1 | 890.3850 | 2025-07-25 |
| INM | Chair, With Casters | Physical Medicine | Class 1 | 890.3100 | 2025-07-25 |
| IOR | Wheelchair, Mechanical | Physical Medicine | Class 1 | 890.3850 | 2025-07-28 |
| IMP | Cushion, Wheelchair | Physical Medicine | Class 1 | 890.3920 | 2001-05-09 |
| FSA | Lift, Patient, Non-Ac-Powered | General Hospital | Class 1 | 880.5510 | 2001-05-09 |
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | Class 1 | 868.5340 | 2013-12-10 |
| FOX | Stand, Infusion | General Hospital | Class 1 | 880.6990 | 2001-05-09 |
| IOR | Wheelchair, Mechanical | Physical Medicine | Class 1 | 890.3850 | 2025-07-25 |
| FNM | Mattress, Air Flotation, Alternating Pressure | General Hospital | Class 2 | 880.5550 | 2003-12-08 |
| KIC | Cushion, Flotation | Physical Medicine | Class 1 | 890.3175 | 2013-12-10 |
| ITJ | Walker, Mechanical | Physical Medicine | Class 1 | 890.3825 | 2001-05-09 |
| IOR | Wheelchair, Mechanical | Physical Medicine | Class 1 | 890.3850 | 2025-07-25 |
| CAW | Generator, Oxygen, Portable | Anesthesiology | Class 2 | 868.5440 | 2025-07-25 |
| KDQ | Bottle, Collection, Vacuum | General Hospital | Class 2 | 880.6740 | 2025-07-25 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | Class 2 | 868.5630 | 2025-07-25 |
| BTI | Compressor, Air, Portable | Anesthesiology | Class 2 | 868.6250 | 2025-07-25 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3009056001 | STME Acquisition LLC | Palmetto, GA, US |
| 1062191 | Inovo Inc. | Lehigh Acres, FL, US |
| 3044563261 | Drive Northpoint, LLC | Palmetto, GA, US |
| 3015772781 | Drive DeVilbiss Healthcare | Palmetto, GA, US |
| 3009683397 | Drive DeVilbiss Healthcare | Dayton, NJ, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K163485 | Adherium (Nz), Ltd. | SmartTouch | 2017-08-30 |
| K781467 | Travenol Laboratories, S.A. | U-FLOAT VALVE 2D9023 | 1978-09-07 |
| K830425 | Maddak, Inc. | TOILET SEAT RAISED | 1983-05-09 |
| K935211 | Brookefield Hunter, Inc. | WALK N CHAIR | 1994-02-02 |
| K832685 | Health America | WHEELCHAIR-VARIOUS MODELS | 1983-09-20 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0011-2015 | Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056 | 1 | Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010. |
| Z-0031-2013 | Winco Mfg., LLC | 1 | Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***"
Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***"
Patient recliner chair |
| Z-0032-2013 | Winco Mfg., LLC | 1 | Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***"
Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***"
Patient recliner chair |
| Z-0013-2018 | Handicare Usa Inc | 1 | PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered |
| Z-0014-2018 | Handicare AB Maskinvagen | 1 | Carina Mobile Lifts, Models:
a) Carina350EM, REF 6060011
b) Carina350EML, REF 60600012
c) Carina350EE, REF 60600009 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9615415 | PRIME PACIFIC HEALTH INNOVATIONS CORPORATION | PORT COQUITLAM British Columbia, CA |
| 2242467 | HAUSMANN ENTERPRISES, LLC | NORTHVALE, NJ, US |
| 1063324 | REACT Innovations | Charlotte, NC, US |
| 3005214422 | HOMECARE ENTERPRISE CO., LTD. | Changhua City, TW |
| 3008533516 | Intensa, Inc. | High Point, NC, US |
3043460907 when referencing this establishment in official correspondence.