510(k) K971400
- Device
- Muscle Response Monitor
- Applicant
- ENRICHING YOUR LIFE
- 510(k) number
- K971400
- Product code
- HCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-04-14
- Date received
- 1997-04-15
- Regulation
- 882.5050
- Classification name
- Device, Biofeedback
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY LOU WILSON
- Address
- 6339 Kelly Dr. Granbury TX US 76048 76048
FDA Registration Numbers#
- 2084126
- 3006418479
- 3027256314
- 3027475369
- 3016427447
- 3038189172
- 3014661062
- 3008414621
- 1921846
- 3010887638
- 3023272766
- 3031357177
- 3006978331
- 1423537
- 3013263129
- 3012316249
- 3016735640
- 3045178683
- 3007075140
- 3008248575
- 3018317166
- 3013755083
- 3019892999
- 3042226194
- 1721293
- 3013013401
- 3014209670
- 3010129717
- 3009118691
- 3030348157
- 3005024415
- 3004839404
- 3013517104
- 3007502541
- 3009351773
- 3009466220
- 3000126629
- 3009862126
- 3007028037
- 3006644670
- 3003176094
- 3019822804
- 3007608780
- 3016159413
- 3016566173
- 3011088301
- 1317927
- 3011905669
- 8021957
- 3025350087
- 9680487
- 3014732
- 3006240003
- 3017264244
- 3011255064
- 3006655502
- 3004642067
- 3018783526
- 3006789226
- 3005998761
- 3010361494
- 3012164803
- 3013413442
- 3013401749
- 3007712511
- 9616086
- 1223851
- 3011089437
- 3003755374
- 1930027
- 3011883032
- 3015542403
- 3005196642
- 3012094189
- 3015497638
- 9611612
- 3011410128
- 3006177498
- 3012697062
Source Documents#
510(k) summary PDF not indicated by FDA
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| K073557 | EEG NEUROAMP, MODEL CS10137 | Corscience GmbH & Co. KG | 2008-02-28 |
| K071866 | NTRAINER SYSTEM | Kcbiomedix, Inc. | 2008-02-01 |
| K071661 | ALPHAONE BIOFEEDBACK SYSTEM | Telediagnostic Systems, Inc. | 2007-09-05 |
| K041244 | POLYGRAM NET BIOFEEDBACK APPLICATION | Medtronic Vascular | 2004-08-12 |
| K020399 | RESPERATE; MODEL RR-150 | Intercure , Ltd. | 2002-07-02 |