Hand, External Limb Component, Powered
Physical Medicine · 21 CFR 890.3420
Recent MDR events
15 adverse event reports on file
- FLEXCELLJul 9, 2026MalfunctionInfinite Biomedical Technologies Llc3004426795-2026-00001
- MYOMOPRO 2XFeb 19, 2026InjuryMyomo, Inc.MW5184094
- FLEXCELLJun 5, 2025MalfunctionInfinite Biomedical Technologies Llc3004426795-2025-00002
- FLEXCELLDec 12, 2024MalfunctionInfinite Biomedical Technology, Llc3004426795-2024-00001
- KINOVAJul 26, 2024MalfunctionKinova3009538853-2024-00001
- I-LIMB ACCESSAug 31, 2023DeathTouch Bionics Ltd.3006532285-2023-00001
- FLEXCELLSep 24, 2022MalfunctionInfinite Biomedical Technologies Llc3004426795-2022-00006
- FLEXCELL MINIAug 25, 2022MalfunctionInfinite Biomedical Technologies Llc3004426795-2022-00005
- JACOAug 22, 2022InjuryKinovaMW5111629
- FLEXCELLJul 8, 2022MalfunctionInfinite Biomedical Technologies Llc3004426795-2022-00002
Event type breakdown
Recalls
2 recall events for this product code
- Kinova IncOpen, ClassifiedOct 11, 2024
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on
Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.
Z-0049-2025 · View FDA record ↗ - Motion Control, Inc.TerminatedJul 6, 2005
Spectre brand AC wall adapter to be used with ProControl 2 or ProHand battery powered upper limb prosthesis.
Incorrect AC wall adapter was distributed with prostheses. Incorrect use of adapters could damage the battery and cause a potential fire hazard.
Z-0959-05 · View FDA record ↗
Registered firms
48 firms currently registered for this product code
Ottobock Se & Co. Kgaa Formerly Known As Otto Bock Healthcare Gmbh
DUDERSTADT Lower Saxony, DE
Hugh Steeper Ltd Dba Steeperusa
Hopkinton, MA, US
Teh Lin Prosthetic & Orthopaedic, Inc.
TAIPEI, TW
Bioservo Ab
Kista Stockholm, SE
Aether Biomedical Sp. Z O.o.
Poznan Wielkopolskie, PL
Foshan Hongfeng Co.,ltd
Foshan Guangdong, CN
Bionit Labs S.r.l.
Soleto Lecce, IT
Touch Bionics Ltd
Livingston West Lothian, GB
Infinite Biomedical Technologies, Llc
Baltimore, MD, US
Coapt Llc
Chicago, IL, US
Otto Bock Healthcare Products Gmbh
Vienna Wien, AT
Mand.ro Co., Ltd.
Bucheon-si Gyeonggi, KR
Alt-bionics, Inc.
San Antonio, TX, US
Medex Medical Supplies Ltd.
China Guangdong, CN
Psyonic
San Diego, CA, US
Cascade Orthopedic Supply, Lp.
Chico, CA, US
Oymotion Technologies Co., Ltd.
shanghai, CN
Ossur Iceland Ehf.
REYKJAVIK, IS
Vincent Systems Gmbh
Karlsruhe Baden-Wurttemberg, DE
Open Bionics
Bristol Bristol, City of, GB
Ossur Americas
West Deptford, NJ, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.