FCOClass I
Box, Battery, Rechargeable
Gastroenterology, Urology · 21 CFR 876.1500
MDR events104All time
Recalls0All time
Registered firms9Currently listed
510(k) clearances20All time
Recent MDR events
104 adverse event reports on file
- I-STAT RECHARGEABLE POWER PACKNov 21, 2023MalfunctionAbbott Point Of Care2245578-2023-00165
- I-STAT RECHARGEABLE POWER PACKNov 14, 2023MalfunctionAbbott Point Of Care2245578-2023-00160
- I-STAT RECHARGEABLE POWER PACKNov 14, 2023MalfunctionAbbott Point Of Care2245578-2023-00164
- I-STAT RECHARGEABLE POWER PACKAug 30, 2023MalfunctionAbbott Point Of Care2245578-2023-00112
- R&D BATTERIESAug 14, 2023InjuryR&d Batteries, Inc.MW5144570
- I-STAT RECHARGEABLE POWER PACKJul 7, 2020MalfunctionAbbott Point Of Care2245578-2020-00072
- ENOVATE MEDICALNov 13, 2017Enovate MedicalMW5073262
- MOBIUS POWER 3.5 BATTERY PACKOct 27, 2017InjuryEnovate Medical/ Stinger MedicalMW5072979
- ENOVATE MEDICAL MOBIUS POWERDec 15, 2016OtherEnovate MedicalMW5066736
- RUSCH TRULED ADULT RECHARGEABLE BATTERYAug 22, 2016MalfunctionTeleflex Medical3011137372-2016-00243
Event type breakdown
Malfunction75
Other16
Injury7
Unspecified6
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
510(k) clearances
20 clearances for this product code
- Portable Power Systems, Inc.Aug 2, 1995
K946080 · PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR
- R & D Batteries, Inc.Mar 23, 1995
K944348 · R&D BATTERIES, INC. PART NO. 5128, 5053, 5007
- R & D Batteries, Inc.Mar 23, 1995
K944389 · R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153
- R & D Batteries, Inc.Mar 23, 1995
K945870 · R&D PART NOS. 5490, 5541, 5358, 5497
- R & D Batteries, Inc.Mar 23, 1995
K944388 · R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100
- R & D Batteries, Inc.Mar 6, 1995
K944521 · RECHARGEABLE BATTERIES
- R & D Batteries, Inc.Mar 6, 1995
K945868 · R&D PART NOS. 5262, 5543, 5432, 5469
- R & D Batteries, Inc.Mar 2, 1995
K944387 · R&D BATTERIES PART NOS. 5186 AND 5230