FDA Device Registration & Listing · DURYEA, PA, US · Registration 2531465
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | Class 2 | 890.3800 | 2008-04-22 |
| KNL | Board, Scooter, Prone | Physical Medicine | Class 1 | 890.5370 | 2012-08-21 |
| ITI | Wheelchair, Powered | Physical Medicine | Class 2 | 890.3860 | 2015-07-29 |
| ITI | Wheelchair, Powered | Physical Medicine | Class 2 | 890.3860 | 2008-04-22 |
| IOR | Wheelchair, Mechanical | Physical Medicine | Class 1 | 890.3850 | 2011-08-23 |
| FSA | Lift, Patient, Non-Ac-Powered | General Hospital | Class 1 | 880.5510 | 2015-06-03 |
| INM | Chair, With Casters | Physical Medicine | Class 1 | 890.3100 | 2012-08-21 |
| KNN | Components, Wheelchair | Physical Medicine | Class 1 | 890.3920 | 2012-08-21 |
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | Class 2 | 890.3800 | 2008-04-22 |
| IMR | Device, Anti-Tip, Wheelchair | Physical Medicine | Class 1 | 890.3920 | 2012-08-21 |
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | Class 2 | 890.3800 | 2008-04-22 |
| INO | Chair, Positioning, Electric | Physical Medicine | Class 2 | 890.3110 | 2009-12-04 |
| INN | Chair, Adjustable, Mechanical | Physical Medicine | Class 1 | 890.3100 | 1988-06-23 |
| KID | Restraint, Wheelchair, Non-Protective | Physical Medicine | Class 1 | 890.3910 | 2012-08-21 |
| ITI | Wheelchair, Powered | Physical Medicine | Class 2 | 890.3860 | 2008-04-22 |
| IML | Armrest, Wheelchair | Physical Medicine | Class 1 | 890.3920 | 2012-08-21 |
| IQB | Belt, Wheelchair | Physical Medicine | Class 1 | 890.3920 | 2012-08-21 |
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | Class 2 | 890.3800 | 2008-04-22 |
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | Class 2 | 890.3800 | 2009-03-30 |
| ITI | Wheelchair, Powered | Physical Medicine | Class 2 | 890.3860 | 2008-04-22 |
| INA | Hill Holder, Wheelchair | Physical Medicine | Class 1 | 890.3920 | 2012-08-21 |
| IMZ | Holder, Crutch And Cane, Wheelchair | Physical Medicine | Class 1 | 890.3910 | 2012-08-21 |
| ITI | Wheelchair, Powered | Physical Medicine | Class 2 | 890.3860 | 2012-03-02 |
| ITI | Wheelchair, Powered | Physical Medicine | Class 2 | 890.3860 | 2022-07-05 |
| ITI | Wheelchair, Powered | Physical Medicine | Class 2 | 890.3860 | 2008-04-22 |
| INO | Chair, Positioning, Electric | Physical Medicine | Class 2 | 890.3110 | 2008-04-22 |
| IMS | Support, Head And Trunk, Wheelchair | Physical Medicine | Class 1 | 890.3910 | 2012-08-21 |
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | Class 2 | 890.3800 | 2008-04-22 |
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | Class 2 | 890.3800 | 2008-04-22 |
| KNO | Accessories, Wheelchair | Physical Medicine | Class 1 | 890.3910 | 2012-08-21 |
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | Class 2 | 890.3800 | 2009-05-18 |
| IMY | Armboard, Wheelchair | Physical Medicine | Class 1 | 890.3910 | 2012-08-21 |
| IMX | Board, Lap, Wheelchair | Physical Medicine | Class 1 | 890.3910 | 2012-08-21 |
| IMW | Brake, Extension, Wheelchair | Physical Medicine | Class 1 | 890.3920 | 2012-08-21 |
| INO | Chair, Positioning, Electric | Physical Medicine | Class 2 | 890.3110 | 2008-04-22 |
| IMO | Handrim, Wheelchair | Physical Medicine | Class 1 | 890.3920 | 2012-08-21 |
| IMM | Footrest, Wheelchair | Physical Medicine | Class 1 | 890.3920 | 2012-08-22 |
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | Class 2 | 890.3800 | 2009-07-24 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 2531618 | MEGA MOTION, INC. | Duryea, PA, US |
| 3012425482 | PRIDE MOBILITY PRODUCTS CORPORATION | Pontotoc, MS, US |
| 3004473024 | STEALTH PRODUCTS | BURNET, TX, US |
| 3044470904 | Pride Mobility Products Corporation | North Las Vegas, NV, US |
| 3007608806 | PRIDE MOBILITY PRODUCTS CORP. | North Las Vegas, NV, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K853594 | Vessa , Ltd. | VESSA FLIVVA | 1985-09-24 |
| K142783 | Heartway Medical Products Co., Ltd. | HEARTWAY Electrically Powered Wheelchair P27 | 2015-06-12 |
| 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-0036-2007 | Medline Industries Inc | 2 | Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue |
| Z-0037-2007 | Medline Industries Inc | 2 | Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807650 - red and MDS807650B - blue |
| Z-0005-2018 | Permobil, Ab Arvaltsvagen 10 | 2 | Electric Wheelchairs:
a) C300 CORPUS II
b) C350 CORPUS II
c) C400 CORPUS II
d) C400 CORPUS II LR
e) C500 CORPUS II
f) C500 CORPUS II LR |
| Z-0006-2018 | Permobil, Ab Arvaltsvagen 10 | 2 | Electric Wheelchair bases:
a) C300
b) C350
c) C400
d) C500 |
| Z-0039-2007 | Eagle Parts and Products | 2 | Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3043153502 | ZHEJIANG TAOTAO VEHICLE CO.,LTD | Lishui City Zhejiang, CN |
| 3016733848 | Guangdong Zhanyuan Smart Science and Technology Co. Ltd. | Dalang Town, Dongguan City Guangdong, CN |
| 3008841035 | Guangdong Prestige Technology Co., Ltd. | Dongguan Guangdong, CN |
| 9616873 | WU'S TECH CO., LTD. | Hsin-Chu City Hsinchu, TW |
| 3004594214 | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | Zhongshan City Guangdong, CN |
2531465 when referencing this establishment in official correspondence.