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Exerciser, Measuring
FDA product code ISD · Class 2 · Physical Medicine
293
Registered devices
35
Adverse events
2
Recalls
61
510(k) clearances
Devices with this code
StroopVR — VIRTUALISE-LINK R500 ROM Kit (Range of Motion) — BIOMETRICS LIMITEDExer Scan — Exer Labs, Inc.Digital Therapist — SWORD HEALTH, S.A.Head-Eye-Coordination — VIRTUALISVRCogni — XR HEALTH IL LTDExer Gait — Exer Labs, Inc.PhysioVR — VIRTUALISXR Therapy System — Neuromersive, Inc.Lode B.V. — Lode B.V.Digitsole Pro — DIGITSOLESPLY EBIKE CUFF ADULT LARGE — ergoline GmbHTOTAL BODY KIT – 12 WISE — NCS LAB SRLWhac-a-Mush — VIRTUALISBiometrics Ltd M550 MyoMeter — BIOMETRICS LIMITEDLode B.V. — Lode B.V.Lode B.V. — Lode B.V.Digital Therapist — SWORD HEALTH, S.A.Actigraph — ACTIGRAPH L.L.C.Digital Therapist — SWORD HEALTH, S.A.Recumbent Ergometer ergoselect 600 P BP — ergoline GmbHRod & Frame Test — VIRTUALISE-LINK X4 Interface Unit — BIOMETRICS LIMITEDNUSHU — Magnes AG
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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