Data / Medical devices / United States / Personal Medical Corp.
Personal Medical Corp.: FDA-registered device maker in Bothell, WA, United States, 5 510(k) clearances
Personal Medical Corp. is registered with the FDA (registration 3021815) in Bothell, WA, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 24, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021815
- Address
- 11824 N Creek Pkwy N Ste 101, Bothell, WA, United States, 98011
- Owner or operator
- Personal Medical Corp. (10042794)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 31, 2012
- Registered through
- 2026
- Brand names listed
- C3®/Regain penile clamps, EvaCare® Pessaries, InWave Pelvic Floor Stimulator, MEP Anal and IVS-2 Intravaginal EMG Sensors, SenseRx Anal/Small Vaginal and Vaginal EMG Sensors, StepFree vaginal weights
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Penile | FHA | 1 | Manufacturer | accessdata.fda.gov |
| Components, Exercise | IOD | 1 | Manufacturer | accessdata.fda.gov |
| Perineometer | HIR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pessary, Vaginal | HHW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| August 24, 2012 | K121820 | INWAVE | KPI | Substantially Equivalent | Zynex Medical, Inc. | accessdata.fda.gov |
| November 29, 2000 | K002834 | SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR | HIR | Substantially Equivalent | Srs Medical Systems, Inc. | accessdata.fda.gov |
| December 13, 1999 | K993308 | MENTOR EVACARE VAGINAL PESSARIES | HHW | Substantially Equivalent | Mentor Corp. | accessdata.fda.gov |
| July 14, 1998 | K974040 | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | FHA | Substantially Equivalent | Timm Research Co. | accessdata.fda.gov |
| August 26, 1994 | K926218 | EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) | HIR | Substantially Equivalent | Sandhill Scientific, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Perineometer
- All makers of Clamp, Penile
- All makers of Pessary, Vaginal
- All makers of Components, Exercise
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
Updated August 24, 2012. 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.