Product code ISD— Physical Medicine
3-D PASSIVE MOBILIZER
- Classification name
- Exerciser, Measuring
- Device class
- Class 2
- Regulation
- 21 CFR 890.5360
- Advisory panel
- Physical Medicine
- Total cleared
- 61
- First cleared
- Most recent
Market context for product code ISD
FDA has cleared devices under product code ISD between 1977 and 2020, filed by 42 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2020
- 2019
- 2015
- 2012
- 2008
- 2006
- 1999
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1989
- 1988
Top applicants under product code ISD
Adverse events under product code ISD
product code ISD- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code ISD
- K202979 — MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
- K183296 — REAL Immersive System
- K143512 — ActiSpec Activity Monitor
- K112121 — ERGOSELECT/GE
- K080545 — ACTITRAINER
- K053078 — ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
- K990866 — QUINTON MEDTRACK CR PLUS TREADMILL
- K990813 — REHCOR
- K962855 — ULE-2, MULE-2, HAND ACCESSORY KIT
- K952163 — DAVID BACK CLINIC SYSTEM
- K941033 — PHYSIO HAB
- K940065 — SES100
- K934238 — MULE
- K930735 — LORDEX LUMBAR EXTENSION MACHINE
- K933611 — THE BTE WS30
- K926278 — STAIR CLIMBER
- K926279 — UPPER BODY EXERCISER
- K926287 — EXERCISE BICYCLE
- K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER
- K930253 — CARDIO2 CTCKE
- K926170 — STEPMILL EXERCISE SYSTEM
- K922602 — CABLE COLUMN WEIGHT SYSTEM MODEL #940-200
- K922603 — TOTAL WORK INTEGRATOR, MODEL #940-110
- K922606 — MULTI JOINT WEIGHT SYSTEM MODEL #940-100
- K912140 — STAIRMASTER MODEL 6000 ERGOMETER
- K912056 — GRAVITRON UPPER BODY SYSTEM EXERCISER
- K912057 — 4000 PT EXERCISE SYSTEM
- K912058 — GAUNTLET STAIR CLIMBER
- K912227 — MONARK ERGOMETERS
- K904823 — FLEXERCYCLE
- K894154 — METABOLIC SYSTEMS
- K890401 — GOLDEN MEAN MACHINE(TM) (CLASS 2)
- K880032 — MEDEX MACHINE
- K880271 — RESUBMITTED EXCALIBUR
- K871494 — UPPERCYCLE STATIONARY EXERCISE MACHINES
- K870872 — DISCIPLINE I
- K864581 — APPLIDYN
- K863884 — PULSESTAR EXERCISE BIKE
- K861348 — R1361 & R1372 MEASURED EXERCISE EQUIPMENT
- K851946 — REMOTE SPEED CONTROL
- K851967 — TORQUE FEEDBACK METER
- K851097 — LODE MODEL CORIVAL ERGOMETER
- K850869 — MFE COUCH ERGOMETER
- K843850 — UNIVERSAL-ERGOTEST
- K834360 — 3-D PASSIVE MOBILIZER
- K834098 — STATIONARY EXERCISE BICYCLE
- K832940 — ROTAGYM
- K801868 — CAL-COUNT
- K800939 — COMPUTRIM 900
- K800892 — NUCLEAR STRESS TABLE (NST-1)
- K800072 — DIGITAL ELECTRONIC EXERCISER/PULSE MTR.
- K792591 — STRESS TABLE/ERGOMETER SYSTEM
- K792120 — AEROBITRON II
- K792121 — AEROBITRON III
- K791966 — AEROBITRON 1
- K791866 — STANDARD HEALTH BIKE MODEL 019
- K781997 — AUTORANGE
- K781889 — COLLINS PEDALMATE 2
- K770234 — MODEL 880 REHABILITATION TRAINER
- K770148 — CALIBRATED GRASPING TUBES
- K770164 — FINGER MUSCLE TESTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.