Newport Medical
Air Compressor System, 120VAC, 60Hz, 5.6 Amp
23manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (8), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Nantong Kangjinchen Medical Equipment Co., Ltd. | Nantong | Jiangsu | Manufacturer | 17 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Showing 12 of 23. All 23 manufacturers in China registered for Compressor, Air, Portable
Record
| Listed by | Newport Medical Instruments, Inc., United States |
|---|---|
| FDA product code | BTI |
| Device type | Compressor, Air, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.6250 |
| 510(k) | K091871 |
| Record published | 2016-09-24 |
| Record revised | 2023-12-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Handling environment humidity 10 to 95 % RH; Handling environment temperature 15 to 40 °C; Storage environment temperature -25 to 55 °C; Special storage condition: This side up;Fragile |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C235-120V-60-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| InnoSpire Elegance | Respironics Respiratory Drug Delivery (Uk), Ltd. | 124 |
| InnoSpire Essence | Respironics Respiratory Drug Delivery (Uk), Ltd. | 37 |
| Medline | Medline Industries, Inc. | 28 |
| Roscoe Medical | Drive DeVilbiss Healthcare | 19 |
| Drive | Drive DeVilbiss Healthcare | 18 |
| Timeter | Allied Medical LLC | 16 |
| DK50 DS | Ekom Spol. S R.O. | 11 |
| V8800 Critical Care Ventilator | Oricare Inc. | 10 |
| Medquip | Drive DeVilbiss Healthcare | 9 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 6 |
| MedPak | Lifeport, LLC. | 5 |
| Carex Health Brands | Drive DeVilbiss Healthcare | 5 |
Showing 12 of 101. All products under Compressor, Air, Portable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K041406 | 2004-12-15 |
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.