Data / Medical devices / United States / Pepin MFG., Inc.
Pepin MFG., Inc.: FDA-registered device maker in Lake City, MN, United States, 1 510(k) clearance
Pepin MFG., Inc. is registered with the FDA (registration 2132556) in Lake City, MN, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 23, 2007. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2132556
- FEI number
- 1000221051
- Address
- 1875 Hwy 61 South, Lake City, MN, United States, 55041
- Owner or operator
- PEPIN MFG., INC. (9007792)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 10, 2007
- Registered through
- 2026
- Brand names listed
- AdvanTrode®, CUTANEOUS ELECTROTHERAPY, DuraFuse
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clip, Implantable | FZP | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Skin Closure | MKY | 1 | Contract manufacturer | accessdata.fda.gov |
| Topical Approximation System | MZR | 1 | Contract manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| May 23, 2007 | K070807 | CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES | GXY | Substantially Equivalent | Pepin Mfg., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Clip, Implantable
- All makers of Electrode, Cutaneous
- All makers of Monitor, Breathing Frequency
- All makers of System, Skin Closure
- All makers of Ventilatory Effort Recorder
- All makers of Topical Approximation System
Updated May 23, 2007. 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.