Kunshan Hi-Fortune Health Products Co., Ltd.
Manufacturer and brand owner in Kunshan, Jiangsu, China. 32 device types, 7 products catalogued, 9 clearances.
Kunshan Hi-Fortune Health Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Belt, Wheelchair, Walker, Mechanical and 30 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2011.
32device types registered with the FDA
7products catalogued under its own name
9510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3009265647 |
| FEI number | 3009265647 |
| DUNS | 548310008 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Kunshan |
|---|---|
| Province | Jiangsu |
| Address | NO.625 Juxiang Road, Zhangpu Town |
| Postal code | 215321 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Wheelchair | Class 1 | MEDICAL DEPOT d/b/a Drive DeVilbiss Healthcare, Pride Mobility Products Corp | 2012 | 80 |
| Armboard, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 14 |
| Armrest, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 29 |
| Attachment, Commode, Wheelchair | Class 1 | toilet lift-LT100, commode chair | 2019 | 70 |
| Bed, Therapeutic, Ac-Powered, Adjustable Home-Use | Class 2 | Adjustable mattress | 2015 | 19 |
| Belt, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 24 |
| Board, Lap, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 14 |
| Board, Scooter, Prone | Class 1 | Pride Mobility Products Corp | 2012 | 8 |
| Brake, Extension, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 19 |
| Chair, Adjustable, Mechanical | Class 1 | Pride Mobility Products Corp | 2012 | 46 |
| Chair, With Casters | Class 1 | Pride Mobility Products Corp | 2012 | 85 |
| Climber, Curb, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 13 |
| Components, Exercise | Class 1 | Wobble board (23301) Rocker board (23300 | 2012 | 31 |
| Components, Wheelchair | Class 1 | MEDICAL DEPOT d/b/a Drive DeVilbiss Healthcare, Pride Mobility Products Corp | 2012 | 54 |
| Cuff, Pusher, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 11 |
| Cushion, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 53 |
| Device, Anti-Tip, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 22 |
| Device, Patient Transfer, Powered | Class 2 | patient lift–HY108 adn HY101-01A HY201 HY601 HY603 | 2017 | 27 |
| Footrest, Wheelchair | Class 1 | Manual wheelchair accessary(Footrest), Pride Mobility Products Corp | 2012 | 25 |
| Handrim, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 12 |
| Hill Holder, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 9 |
| Holder, Crutch And Cane, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 22 |
| Lift, Patient, Ac-Powered | Class 2 | Kunshan Hi-Fortune Health Products Co.,Ltd, Toilet lift seat-TLS200, Hydraulic Patient Lift HY106, Electric Patient Lift HY108, HY201 | 2017 | 27 |
| Lift, Patient, Non-Ac-Powered | Class 1 | Ceiling hoist-CH100 | 2020 | 71 |
| Powered Stairway Chair Lift | Class 2 | Pridemobility | 2018 | 5 |
| Restraint, Wheelchair, Non-Protective | Class 1 | Pride Mobility Products Corp | 2012 | 15 |
| Splint, Hand, And Components | Class 1 | lift belt | 2021 | 144 |
| Support, Head And Trunk, Wheelchair | Class 1 | Pride Mobility Products Corp | 2012 | 10 |
| Vehicle, Motorized 3-Wheeled | Class 2 | GoGo Super Portable, Pride, Revo S66, Scooter Model R, Revo S67, Baja Bandit | 2018 | 41 |
| Walker, Mechanical | Class 1 | NIP Rollator | 2017 | 183 |
| Wheelchair, Mechanical | Class 1 | Litestream XF HD, Stylus, Stylus LS, Litestream 500E/Litestream XF, Mechanical Wheelchair | 2011 | 46 |
| Wheelchair, Powered | Class 2 | Electrically Powered Wheelchair, Pride Mobility Products Corp, 1450, HP358EA Electrically Powered Wheelchair, Electrically Powered Wheelchair (HP206), Electric Wheelchair and 10 more | 2014 | 62 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Hi-Fortune | ITI | 8 |
| Hi-Fortune | FNG | 5 |
| Hi-Fortune | FRZ | 2 |
| Hi-Fortune | IMN | 2 |
| Adjustable mattress | LLI | 1 |
| Hi-Fortune | KNL | 1 |
| Hi-Fortune | IOR | 1 |
Clearances
9 clearances name Kunshan Hi-Fortune Health Products Co., Ltd. as applicant. 5 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K244003 | 2025-03-26 | ITI | Traditional | This company |
| K243961 | 2025-02-12 | ITI | Special | This company |
| K243962 | 2025-02-12 | ITI | Special | This company |
| K241337 | 2024-10-17 | ITI | Traditional | This company |
| K241632 | 2024-10-16 | ITI | Traditional | This company |
| K212503 | 2022-01-18 | ITI | Traditional | This company |
| K211647 | 2022-01-04 | ITI | Traditional | This company |
| K201855 | 2021-09-28 | ITI | Traditional | This company |
| K163352 | 2017-07-28 | IOR | Traditional | This company |
| K112815 | 2012-02-29 | ITI | Special | Pride Mobility Product Corporration |
| K092961 | 2009-10-23 | ITI | Special | Pride Mobility Products Corp. |
| K072165 | 2007-08-17 | INI | Special | Pride Mobility Products Corp. |
| K071949 | 2007-08-01 | INI | Special | Pride Mobility Products Corp. |
| K042612 | 2004-10-06 | ITI | Special | Pride Mobility Products Corp. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Main products | Power wheelchairs, Manual wheelchairs, Home care beds, Patient lifts, Electric scooters |
| Export markets | Europe, North America, Japan, Korea, China |
Nearby Manufacturers
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.
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