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Exerciser, Measuring
FDA product code ISD · Class 2 · Physical Medicine
286
Registered devices
34
Adverse events
2
Recalls
61
510(k) clearances
Devices with this code
Couch Ergometer ergoselect 12 — ergoline GmbHAnalogue Interface Module ergoselect2 — ergoline GmbHDigital Therapist — SWORD HEALTH, S.A.Bioness Integrated Therapy System, BITS 3.0, BITS Balance — Bioness Medical, Inc.SYSTEM EBIKE EL 120V US — ergoline GmbHE-LINK Myo-EX GX3 EMG Sensor — BIOMETRICS LIMITEDVRPhysio — XR HEALTH IL LTDSeat Ergometer ergoselect 100 K — ergoline GmbHSeat Ergometer ergoselect 100 P — ergoline GmbHERGOMETER ergoselect 4 T — ergoline GmbHSPLY EBIKE CUFF ADULT LARGE — ergoline GmbHLode B.V. — Lode B.V.E-LINK DG1 Wireless Dongle — BIOMETRICS LIMITEDREAL y-Series — PENUMBRA, INC.LOWER LIMB KIT – 6 WISE — NCS LAB SRLAccess Point V2C — APDM WEARABLE TECHNOLOGIES, INC.BITS Motion Sensor — BIONESS INC.Exer Scan — Exer Labs, Inc.Mirror & Ball — VIRTUALISPhysioVR — VIRTUALISblood pressure cuff (BNC), standard — ergoline GmbHLode B.V. — Lode B.V.DS5 — Foresite Healthcare, LLCLode B.V. — Lode B.V.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-09 | BTE Technologies, Inc. | 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 hoo |
| 2013-12-03 | MedX Holdings, Inc. | Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. |
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