Shenzhen Flysounds Medical Technology Co., Ltd. (foreign exporter, Shenzhen Guangdong, CN): 1 new FDA device listing, incl. hearing aid, air-conduction with wireless technology, prescription
Shenzhen Flysounds Medical Technology Co., Ltd. (Shenzhen Guangdong): 1 new FDA device listing, incl. hearing aid, air-conduction with wireless technology, prescription. Its amount of 1 is above the median of 2 (50th percentile). Dated 85 days ago, it serves as a historical benchmark. Score 40/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Shenzhen Flysounds Medical Technology Co., Ltd. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Shenzhen Guangdong, CN |
| New listings | 1 |
| Devices | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Product codes | OSM |
| Device classes | Class II |
| Medical specialties | Ear, Nose, Throat |
| Brand names | Hearing aids with models PO1 PO2 PO3 PO4 PO5 PO6 PO7 PO8 PO9 PO10; Hearing aids with models PB1 PB2 PB3 PB4 PB5 PB6 PB7 PB8 PB9 PB10; Hearing aids with models PC1 PC2 PC3 PC4 PC5 PC6 PC7 PC8 PC9 PC10; Hearing aids with models PH1 PH2 PH3 PH4 PH5 PH6 PH7 PH8 PH9 PH10 PH11 PH12 PH13 PH14 PH15 PH16 PH17 PH18 PH19 PH20; Hearing aids with models PR1 PR2 PR3 PR4 PR5 PR6 PR7 PR8 PR9 PR10 PR11 PR12 PR13 PR14 PR15 PR16 PR17 PR18 |
| First new listing | 2026-08-12 |
| Latest new listing | 2026-08-12 |
| FDA registration number | 3034733579 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-12
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Shenzhen Flysounds Medical Technology Co., Ltd. and 720 CN peers
- CN DeviceEstablishmentPulse records like this one: 720
- Shenzhen Flysounds Medical Technology Co., Ltd.'s amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $144,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
40 / 100 Score
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Shenzhen Flysounds Medical Technology Co., Ltd. in Shenzhen Guangdong?
Shenzhen Flysounds Medical Technology Co., Ltd. (Shenzhen Guangdong, CN), a foreign exporter, added 1 FDA device listing on 2026-08-12.
How does Shenzhen Flysounds Medical Technology Co., Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 85 days old; check the official source for later updates before acting.
Shenzhen Flysounds Medical Technology Co., Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Shenzhen Flysounds Medical Technology Co., Ltd. | Shenzhen Guangdong, CN | 1 | 50th | 2026-08-12 |
| Imperial Optical, Inc | Town Of Mount Royal, Quebec, CA | 3 | 77th | 2026-10-22 |
| Kash Sales Inc. | Richmond Hill Ontario, CA | 8 | 90th | 2026-10-16 |
| Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi | Cankaya Ankara, TR | 9 | 92nd | 2026-10-17 |
Related records
DeviceEstablishmentPulse: Foreign exporter DeviceEstablishmentPulse: Foreign establishment
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.