Exerciser, Measuring
Physical Medicine · 21 CFR 890.5360
Recent MDR events
34 adverse event reports on file
- Digital TherapistJun 26, 2026InjurySword Health S.a.3012900326-2026-00003
- DIGITAL THERAPISTMay 8, 2026InjurySword Health S.a.3012900326-2026-00002
- DIGITAL THERAPISTApr 24, 2026InjurySword Health S.a.3012900326-2026-00001
- WGT3X-BTSep 15, 2025OtherActigraph L.l.c.MW5176073
- WGT3X-BTSep 15, 2025OtherActigraph L.l.c.MW5176074
- BIODEX PRESTEP/BIOSTEPNov 22, 2023InjuryBiodex Medical Systems2431314-2017-95256
- BIODEX PRESTEP/BIOSTEPNov 22, 2023InjuryBiodex Medical Systems2431314-2023-95256
- BIODEX PRESTEP/BIOSTEPNov 22, 2023InjuryBiodex Medical Systems2431314-2019-95256
- EXERCISER, MEASURINGOct 27, 2023InjuryActigraph, LlcMW5147441
- PRIMUSDec 23, 2021InjuryBte Technologies1119903-2021-00002
Event type breakdown
Recalls
2 recall events for this product code
- BTE Technologies, Inc.TerminatedJul 6, 2015
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance t
On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap hook. The snap hook could open, resulting in possible injury to the user due to a fall.
Z-1986-2015 · View FDA record ↗ - MedX Holdings, Inc.TerminatedJan 7, 2015
Lumbar Extension Machine
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Z-0935-2015 · View FDA record ↗
Registered firms
79 firms currently registered for this product code
Gkc Manufacturing Pty Ltd
Melbourne Victoria, AU
Medthera Inc.
Waconia, MN, US
Biometrics Ltd.
Newport Wales, GB
Welch Allyn, Inc.
Skaneateles Falls, NY, US
Huanghua Dk Dental Co., Ltd
HuangHua Hebei, CN
Nantong Kangjinchen Medical Equipment Co., Ltd.
Nantong Jiangsu, CN
Seniorlife Technologies Inc
Bellevue, WA, US
Plethy
Santa Clara, CA, US
Guangzhou Homesun Medical Technology Co., Ltd
Guangzhou Guangdong, CN
Foresite Healthcare, Llc
Maryland Heights, MO, US
Ceva Logistics Limited
Daventry Northamptonshire, GB
Celloscope, Ltd
TEL AVIV - JAFFA Central, IL
Exosystems Inc.
Seongnam-si, Gyeonggi-do, KR
Roceso Technologies Pte. Ltd.
Singapore, West South West, SG
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Blatchford Products Limited
BASINGSTOKE Hampshire, GB
Shanghai Wanbo Technology Co., Ltd.
Shanghai, CN
Sword Health S.a.
Porto, PT
Sword Health S.a.
Vila Nova de Gaia Porto, PT
H/p/cosmos Sports & Medical Gmbh
NUSSDORF BEI TRAUNSTEIN Bavaria, DE
Empatica S.r.l.
Milano, IT
Apdm Wearable Technologies, Inc.
Portland, OR, US
Welch Allyn De Mexico, S. De R.l. De C.v.
TIJUANA Baja California, MX
Sword Health, Inc
Salt Lake City, UT, US
510(k) clearances
61 clearances for this product code
- Lode B.V.Dec 21, 2020
K202979 · MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
- Penumbra, Inc.Mar 18, 2019
K183296 · REAL Immersive System
- Sleep Modus, Inc.Aug 26, 2015
K143512 · ActiSpec Activity Monitor
- Ergoline GmbHOct 31, 2012
K112121 · ERGOSELECT/GE
- Actigraph, LLCJul 24, 2008
K080545 · ACTITRAINER
- Ergoline GmbHApr 27, 2006
K053078 · ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
- Quinton, Inc.Apr 29, 1999
K990866 · QUINTON MEDTRACK CR PLUS TREADMILL
- Electromed Corp.Apr 12, 1999
K990813 · REHCOR