Data / Medical devices / South Korea / Saehan Corporation
Saehan Corporation: FDA-registered device maker in Changwon Gyeongnam, South Korea, 1 510(k) clearance
Saehan Corporation is registered with the FDA (registration 8040255) in Changwon Gyeongnam, South Korea. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 27, 2005. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8040255
- FEI number
- 3010581156
- Address
- 23-29, Bongamgongdan 13-gil Masanhoewon-Gu (Masan Free Trade Zone), Changwon Gyeongnam, South Korea, 51342
- Owner or operator
- SAEHAN CORPORATION (8040255)
- Roles
- Manufacturer
- First device listed
- January 24, 1983
- Registered through
- 2027
- Brand names listed
- 6-Piece Goniometer Set, Back-Leg-Chest Dynamometer, Chair Cycle, Clinic Model, Chair Cycle, Deluxe Home Model, Finger Circumference Gauge, Finger Goniometer, Hydraulic Hand Dynamometer, Hydraulic Pinch Gauge and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Traction, Non-Powered | HST | 1 | Manufacturer | accessdata.fda.gov |
| Components, Exercise | IOD | 1 | Manufacturer | accessdata.fda.gov |
| Discriminator, Two-Point | GWI | 1 | Manufacturer | accessdata.fda.gov |
| Dynamometer, Ac-Powered | LBB | 2 | Manufacturer | accessdata.fda.gov |
| Dynamometer, Nonpowered | HRW | 1 | Manufacturer | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer | accessdata.fda.gov |
| Goniometer, Nonpowered | KQW | 1 | Manufacturer | accessdata.fda.gov |
| Pinwheel | GWY | 1 | Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 27, 2005 | K052309 | DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 | LBB | Substantially Equivalent | Saehan Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape, Measuring, Rulers And Calipers
- All makers of Dynamometer, Ac-Powered
- All makers of Pinwheel
- All makers of Exerciser, Non-Measuring
- All makers of Dynamometer, Nonpowered
- All makers of Goniometer, Nonpowered
Updated September 27, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.