Naväge
Nasal Rinse Packet - use to create isotonic saline solution for nasal irrigation
63manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (37), Zhejiang (10), Jiangsu (5). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Cotronic Technology Limited | Shenzhen, Guang Dong | Guangdong | Contract manufacturer | 5 |
| Shantou City KIN Seng Plastic Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Hangzhou Weize IMP & EXP Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 34 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
Showing 12 of 63. All 63 manufacturers in China registered for Irrigator, Powered Nasal
Record
| Listed by | Rhinosystems, Inc., United States |
|---|---|
| FDA product code | KMA |
| Device type | Irrigator, Powered Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5550 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NRP-1 | In distribution | |
| PNC-1 | In distribution | |
| SDG-2.5 OSS-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hydrodebrider® | Medtronic Xomed, Inc. | 9 |
| SinuPulse | Health Solutions Medical Products, Corp. | 4 |
| iHealth | iHealth Labs, Inc. | 3 |
| Berrcom | Guangzhou Berrcom Medical Device Co., Ltd. | 3 |
| InhwRior | Shenzhen Yuechuan Trade Co., Ltd. | 2 |
| Braun | KAZ USA, Inc. | 2 |
| HealthSmart | D-M-S Holdings, Inc. | 2 |
| Bios Diagnostics | Thermor Ltd. | 2 |
| Cleaning sheath for Ø3.1mm X 170mm 45° R | Henke-Sass Wolf, Gmbh. | 1 |
| Cleaning sheath for Ø3.1mm X 170mm 0° | Henke-Sass Wolf, Gmbh. | 1 |
| Cleaning sheath for Ø4mm X 155mm 45° | Henke-Sass Wolf, Gmbh. | 1 |
| Breathe Comfort | Slv Pharmaceuticals LLC | 1 |
Showing 12 of 36. All products under Irrigator, Powered Nasal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140542 | 2014-06-27 |
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.