Jawon Medical Co., Ltd.
Smithfield, VA, US
Jawon Medical Co., Ltd. appears in FDA device records in Smithfield, VA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Jawon Medical Co., Ltd. between 1998 and 2015. The busiest year on record is 2000, with 2. The most recent is 2015, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 1 |
| 2006 | 2 |
| 2007 | 2 |
| 2009 | 2 |
| 2015 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140762 | AUTOMATIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K140045 | BODY COMPOSITION ANALYZER | MNW | Substantially Equivalent | |
| K092432 | AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) | DXN | Substantially Equivalent | |
| K092431 | BODY COMPOSITION ANALYZER, MODEL: IOI 353 | MNW | Substantially Equivalent | |
| K072325 | BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 | MNW | Substantially Equivalent | |
| K071884 | BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 | MNW | Substantially Equivalent | |
| K062462 | NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L | DXN | Substantially Equivalent | |
| K053556 | BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 | MNW | Substantially Equivalent | |
| K013876 | INFRARED EAR THERMOMETER, MODEL DX-707 | FLL | Substantially Equivalent | |
| K002722 | DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 | DXN | Substantially Equivalent | |
| K000675 | MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 | DXN | Substantially Equivalent | |
| K991688 | WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S | DXN | Substantially Equivalent | |
| K983855 | FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F | DXN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Claiming lets Jawon Medical Co., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Jawon Medical Co., Ltd.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain
