510(k) K800892
- Device
- NUCLEAR STRESS TABLE (NST-1)
- Applicant
- TECHNICARE CORP.
- 510(k) number
- K800892
- Product code
- ISD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-05-14
- Date received
- 1980-04-18
- Regulation
- 890.5360
- Classification name
- Exerciser, Measuring
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3041680548
- 3010675897
- 3014657561
- 3012191011
- 3009553578
- 3027475369
- 3006087789
- 3030656808
- 3023272766
- 3025823131
- 3015099260
- 3043177837
- 3011430913
- 3016458361
- 1529102
- 3021907566
- 3014848734
- 3023739055
- 3012933969
- 3029303083
- 3014257280
- 3036471706
- 3012900326
- 8030476
- 3020929899
- 3010331770
- 3033919284
- 1316463
- 3029904430
- 3025488663
- 3014873207
- 3016218294
- 3011806255
- 3017565083
- 3022568093
- 3017994919
- 3011410128
- 3008309560
- 1119903
- 1930027
- 3015282442
- 3022516898
- 3011196543
- 3015422783
- 3015134044
- 3021235837
- 3039642912
- 3006453790
- 8021957
- 3027535342
- 3018783526
- 3003775414
- 3019492433
- 8022890
- 3038285234
- 3000126629
- 3005438755
- 1530895
- 3004091281
- 3012187972
- 3014153685
- 3013463240
- 3035383322
- 9615102
- 3021593882
- 3020967354
- 2916493
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ISD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202979 | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra | Lode B.V. | 2020-12-21 |
| K183296 | REAL Immersive System | Penumbra, Inc. | 2019-03-18 |
| K143512 | ActiSpec Activity Monitor | Sleep Modus, Inc. | 2015-08-26 |
| K112121 | ERGOSELECT/GE | Ergoline GmbH | 2012-10-31 |
| K080545 | ACTITRAINER | Actigraph, LLC | 2008-07-24 |
| K053078 | ERGOSELECT 100 K/P, ERGOSELECT 200 K/P | Ergoline GmbH | 2006-04-27 |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | Quinton, Inc. | 1999-04-29 |
| K990813 | REHCOR | Electromed Corp. | 1999-04-12 |
| K962855 | ULE-2, MULE-2, HAND ACCESSORY KIT | Penny and Giles Biometrics , Ltd. | 1996-12-11 |
| K952163 | DAVID BACK CLINIC SYSTEM | Kinetic Resources, Inc. | 1996-08-12 |
| K941033 | PHYSIO HAB | Longo Industries | 1995-02-27 |
| K940065 | SES100 | Southwest Ergonomics | 1994-12-06 |
| K934238 | MULE | Penny and Giles Biometrics , Ltd. | 1994-10-26 |
| K930735 | LORDEX LUMBAR EXTENSION MACHINE | Lordex, Inc. | 1994-09-29 |
| K933611 | THE BTE WS30 | Baltimore Therapeutic Equipment Co. | 1994-06-20 |
Legacy Summary#
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FDA Review#
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