R82
88 catalogue numbers from x:panda SIZE-4, listed by R82 A/S, Denmark, under Chair, Adjustable, Mechanical. 46 manufacturers in China are registered for this product code.
46manufacturers in China registered for this device type
88catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (20), Jiangsu (12), Zhejiang (7). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 32 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
| 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 |
| Foshan Huafukang Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Zhejiang Kelongwei Medical Equipment Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 10 |
| Three Bears (Jiangsu) Healthcare Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Fran Wheel Enterprise Co., Ltd. | Shen Zhen | Guangdong | Contract manufacturer | 4 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
Showing 12 of 46. All 46 manufacturers in China registered for Chair, Adjustable, Mechanical
Record
| Listed by | R82 A/S, Denmark |
|---|---|
| FDA product code | INN |
| Device type | Chair, Adjustable, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3100 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-12 |
| Record revised | 2023-06-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-06-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| x:panda SIZE-4 | In distribution | |
| High-low:xo SIZE-2 | In distribution | |
| x:panda SIZE-1 | In distribution | |
| Stingray SIZE-1 | In distribution | |
| x:panda SIZE-3 | In distribution | |
| x:panda SIZE-3 | In distribution | |
| x:panda shape infant, w/belt, dynamic lock | In distribution | |
| x:panda SIZE-3 | In distribution | |
| x:panda SIZE-2 | In distribution | |
| x:panda SIZE-4 | In distribution | |
| Strong Base ONE-SIZE | In distribution | |
| x:panda SIZE-1 | In distribution | |
| x:panda SIZE-2 | In distribution | |
| Manatee SIZE-3 | In distribution | |
| x:panda SIZE-1 | In distribution | |
| x:panda SIZE-1 | In distribution | |
| x:panda shape 2, advanced | In distribution | |
| x:panda SIZE-3 | In distribution | |
| x:panda SIZE-4 | In distribution | |
| Manatee SIZE-1 | In distribution | |
| x:panda SIZE-2 | In distribution | |
| x:panda shape 1, simple | In distribution | |
| Manatee SIZE-2 | In distribution | |
| x:panda shape infant L, w/belt | In distribution | |
| x:panda SIZE-2 | In distribution | |
| x:panda SIZE-2 | In distribution | |
| Strong Base ONE-SIZE | In distribution | |
| Manatee SIZE-3 | In distribution | |
| x:panda shape infant, no belt | In distribution | |
| Manatee SIZE-0 | In distribution | |
| x:panda shape infant, w/belt | In distribution | |
| x:panda SIZE-4 | In distribution | |
| High-low:xo SIZE-1 | In distribution | |
| x:panda shape 3, advanced | In distribution | |
| x:panda SIZE-1 | In distribution | |
| x:panda SIZE-2 | In distribution | |
| High-low:xo SIZE-1 | In distribution | |
| Stingray SIZE-1 | In distribution | |
| x:panda SIZE-4 | In distribution | |
| x:panda SIZE-4 | In distribution | |
| x:panda shape 2, simple | In distribution | |
| High-low:xo SIZE-3 | In distribution | |
| x:panda SIZE-2 | In distribution | |
| x:panda SIZE-3 | In distribution | |
| x:panda SIZE-3 | In distribution | |
| High-low:xo SIZE-2 | In distribution | |
| x:panda SIZE-4 | In distribution | |
| High-low:xo SIZE-1 | In distribution | |
| x:panda SIZE-4 | In distribution | |
| x:panda SIZE-3 | In distribution | |
| x:panda SIZE-3 | In distribution | |
| x:panda SIZE-1 | In distribution | |
| x:panda SIZE-3 | In distribution | |
| Stingray SIZE-2 | In distribution | |
| High-low:xo SIZE-1 | In distribution | |
| x:panda SIZE-4 | In distribution | |
| x:panda SIZE-4 | In distribution | |
| x:panda shape 1, advanced | In distribution | |
| x:panda SIZE-3 | In distribution | |
| High-low:xo SIZE-2 | In distribution | |
| x:panda SIZE-3 | In distribution | |
| High-low:xo SIZE-2 | In distribution | |
| x:panda SIZE-2 | In distribution | |
| x:panda SIZE-2 | In distribution | |
| x:panda SIZE-4 | In distribution | |
| x:panda SIZE-1 | In distribution | |
| Manatee SIZE-1 | In distribution | |
| x:panda SIZE-1 | In distribution | |
| x:panda SIZE-1 | In distribution | |
| x:panda shape 3, simple | In distribution | |
| Manatee SIZE-2 | In distribution | |
| x:panda shape infant L, no belt | In distribution | |
| High-Low:x Frame SIZE-1 | Withdrawn | |
| Scallop 3 | Withdrawn | |
| High-Low:x Frame SIZE-1 | Withdrawn | |
| Scallop 1 | Withdrawn | |
| Scallop 2 | Withdrawn | |
| High-Low:x Frame SIZE-2 | Withdrawn | |
| High-Low:x Frame SIZE-1 | Withdrawn | |
| Scallop 2 | Withdrawn | |
| High-Low:x Frame SIZE-3 | Withdrawn | |
| High-Low:x Frame SIZE-2 | Withdrawn | |
| Scallop 3 | Withdrawn | |
| Scallop 1 | Withdrawn | |
| High-Low:x Frame SIZE-2 | Withdrawn | |
| High-Low:x Frame SIZE-2 | Withdrawn | |
| Scallop 4 | Withdrawn | |
| Scallop 4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jenx | Jenx Limited | 612 |
| Plus | Pressalit A/S | 137 |
| Winco | Winco Mfg., LLC | 49 |
| Etac Supply Center AB | Etac Supply Center AB | 42 |
| Champion | Champion Manufacturing Inc. | 40 |
| Staxi | Staxi Corporation | 29 |
| Clinton Industries | Clinton Industries, Inc | 13 |
| JMU | JMU Dental, Inc | 12 |
| Raz | RAZ Design Inc. | 12 |
| ActiveAid | Altimate Medical, Inc. | 11 |
| Staxi | Three Bears (Jiangsu) Healthcare Technology Co., Ltd. | 9 |
| Lumex | GF Health Products, Inc | 9 |
Showing 12 of 157. All products under Chair, Adjustable, Mechanical
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-12-08 | Class II | Process control | The chrome surface of the push brace can crack during use, potentially cutting the user. | 396 units | 2023-09-05 |
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.