Permobil
M300 PS Junior
62manufacturers in China registered for this device type
14catalogue numbers in this listing
11510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Zhejiang (23), Jiangsu (14), Guangdong (10). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 31 |
| Chiaphua Components (Jiangxi) Limited | Yichun | Jiangxi | Contract manufacturer | 23 |
| Feishen Group Co., Ltd. | Yongkang | Zhejiang | Contract manufacturer | 22 |
| Guangdong Marshell Electric Vehicle Co., Ltd. | Zhaoqing | Guangdong | Contract manufacturer | 22 |
| Viscount HI-Tech (Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 17 |
| Zhejiang Linix Motor Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 4 |
| Jiangsu Bangbang Intelligent Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 2 |
| Jinhua Ruidi Vehicle Industry Co Ltd | Zhejiang | Zhejiang | Contract manufacturer | 2 |
| Suzhou Green Pine Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 32 |
| Zhenjiang Assure Medical Equipment Co Ltd | Zhenjiang | Jiangsu | Contract manufacturer | 18 |
Showing 12 of 62. All 62 manufacturers in China registered for Wheelchair, Powered
Record
| Listed by | Permobil, Inc., United States |
|---|---|
| FDA product code | ITI |
| Device type | Wheelchair, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3860 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K143014 |
| Record published | 2016-08-12 |
| Record revised | 2023-07-27 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2017-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F5 | In distribution | |
| M5 | In distribution | |
| M3 | In distribution | |
| K450 | In distribution | |
| Koala | In distribution | |
| M Corpus VS | In distribution | |
| F3 | In distribution | |
| M300 | In distribution | |
| C300 | In distribution | |
| M300 Corpus HD | In distribution | |
| F5 VS | In distribution | |
| M1 | In distribution | |
| C350 | Withdrawn | |
| M400 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Merits | Merits Health Products, Inc. | 186 |
| e-motion® | Alber Gmbh | 129 |
| Modular Power Positioning System | Motion Concepts | 112 |
| e-fix® | Alber Gmbh | 56 |
| TRZ-CG Power Positioning System | Motion Concepts | 54 |
| Batec | Batec Mobility SL. | 48 |
| Drive | Drive DeVilbiss Healthcare | 47 |
| Invacare® TDX® Power Wheelchair | Invacare GmbH | 43 |
| Drivemedical | Drive DeVilbiss Healthcare | 34 |
| Heartway Medical Products Co., Ltd. | Heartway Medical Products Co., Ltd. | 20 |
| Scout | Burke, Inc. | 20 |
| Power Wheelchair | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | 18 |
Showing 12 of 277. All products under Wheelchair, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143180 | 2015-03-27 |
| K143014 | 2015-03-25 |
| K123290 | 2013-04-17 |
| K103477 | 2011-03-03 |
| K081964 | 2008-07-29 |
| K071650 | 2007-09-12 |
| K041219 | 2004-08-04 |
| K032765 | 2004-01-30 |
| K993406 | 2000-12-18 |
| K991658 | 1999-10-08 |
| K960951 | 1997-04-30 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Permobil, Inc. | 510(k) number | 2025-06-19 | Class II | Process design | This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain circumstances | 715 wheelchairs | |
| Permobil, Inc. | 510(k) number | 2024-02-29 | Class II | Process control | This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over, | 140 units | |
| Permobil, Inc. | 510(k) number | 2018-08-15 | Class II | Device Design | This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury. | 3134 units | 2021-05-03 |
| Permobil, Inc. | 510(k) number | 2017-09-01 | Class II | Device Design | There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base. | 5539 units | 2021-05-04 |
| Permobil, Inc. | 510(k) number | 2017-09-01 | Class II | Device Design | There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base. | 146 units | 2021-05-04 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2003-03-07 | Not classified | Other | One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair. | 1,319 | 2008-06-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.