Data / Medical devices / United States / Unipower Corp.
Unipower Corp.: FDA-registered device maker in Minnetonka, MN, United States, 3 510(k) clearances
Unipower Corp. is registered with the FDA (registration 2183890) in Minnetonka, MN, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 7, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183890
- Address
- 6024 Culligan Way, Minnetonka, MN, United States, 55345
- Owner or operator
- OSI Batteries (10087947)
- Roles
- Manufacturer
- First device listed
- May 4, 2023
- Registered through
- 2026
- Brand names listed
- Unipower
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Battery, Replacement, Rechargeable | MOQ | 1 | Manufacturer | accessdata.fda.gov |
| Box, Battery, Pocket | FCP | 1 | Manufacturer | accessdata.fda.gov |
| Dc-Defibrillator, High Energy, (Including Paddles) | DRK | 3 | Manufacturer | accessdata.fda.gov |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Gas Flow | BXP | 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 7, 1994 | K940842 | UNIPOWER RECHARGEABLE BATTERY PACK | LDD | Substantially Equivalent - Subject to Tracking Reg. | Unipower Corp. | accessdata.fda.gov |
| March 31, 1994 | K936141 | UNIPOWER RECHARGEABLE BATTERY PACK | BXP | Substantially Equivalent | Unipower Corp. | accessdata.fda.gov |
| March 28, 1994 | K935111 | UNIPOWERR RECHARGEABLE BATTERY PACK | LDD | Substantially Equivalent | Unipower Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Dc-Defibrillator, Low-Energy, (Including Paddles)
- All makers of Battery, Replacement, Rechargeable
- All makers of Transducer, Gas Flow
Updated September 7, 1994. 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.