Seirin PY-Zero
PY-Zero is a non-invasive and stress-free acupressure device that stimulates through gentle pressing instead of a needle tip. The patented plastic case and sheath enable the practitioner to…
PY-Zero is a non-invasive and stress-free acupressure device that stimulates through gentle pressing instead of a needle tip. The patented plastic case and sheath enable the practitioner to insert the needle without touching the needle tip or the surface of the Micropore adhesive tape. This hypoallergenic, latex-free adhesive allows the skin to breathe during treatment.
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (9), Zhejiang (7). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| China Changsha Pine River Handcraft Moxabustion Co., Ltd. | Changsha | Hunan | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Xiamen Firstcare IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Exporter | 40 |
| Amis (Xiamen) Cultural Creativity Co., Ltd. | Xiamen | Fujian | Manufacturer | 28 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Dongguan Yipincheng Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 17 |
Showing 12 of 36. All 36 manufacturers in China registered for Device, Pressure Applying
Record
| Listed by | Seirin Corporation, Japan |
|---|---|
| FDA product code | KNM |
| Device type | Device, Pressure Applying |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5765 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
| Sizes | Length 0.3 mm; outer diameter 0.2 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PY-Zero 0.3mm | Length 0.3 mm | 100 | In distribution |
| PY-Zero 0.3mm Ø9 | Outer Diameter 0.20 mm | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hansol Medical Co. | Hansol Medical Co. | 14 |
| Hwato Vacuum Cupping Set | Suzhou Medical Appliance Factory | 9 |
| Sensory Vest | Therafin Corporation | 4 |
| Economy Plastic Cups #2 | Dong Bang Medical Co., Ltd. | 3 |
| Economy Plastic Cups #1 | Dong Bang Medical Co., Ltd. | 3 |
| Economy Plastic Cups #5 | Dong Bang Medical Co., Ltd. | 3 |
| Sensory Cuff | Therafin Corporation | 3 |
| Kangci | Health Body World Supply Inc. | 3 |
| Kangzhu | Health Body World Supply Inc. | 3 |
| Economy Plastic Cups #3 | Dong Bang Medical Co., Ltd. | 3 |
| Economy Plastic Cups #4 | Dong Bang Medical Co., Ltd. | 3 |
| Accu-Patch Gold Plated type with Tan Color tape | Sakamura Kenkyusho, K.K. | 2 |
Showing 12 of 125. All products under Device, Pressure Applying
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.