Flexcomp Dsp & Procomp
510(k) K903497
Flexcomp Dsp & Procomp is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K903497 on 12 Feb 1991, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903497 | Date12 Feb 1991 | StatusActive |
Official records
- FDA 510(k) database K903497
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HCC
- FDA applicant
- Thought Technology , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5050
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K903497
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 100 Triodes Self Adhesive T3402M | T3402M | 07540191000241 | On the market | |
| Bend Sensor Assembly SA9550 | SA9550 | 07540191000296 | On the market | |
| DC-EEG 3 DISC ELECTRODE KIT T8770 | T8770 | 07540191000357 | On the market | |
| DC-EEG LINKED EAR ATTACHMENT KIT T8780 | T8780 | 07540191000371 | On the market | |
| DC-EEG MONO/BIPOLAR ELECTRODE KIT T8775 | T8775 | 07540191000364 | On the market | |
| DC-EEG TWO CHANNEL CONNECTIVIT KIT T8785 | T8785 | 07540191000388 | On the market | |
| EEG-Z3 SA7680Z | SA7680Z | 07540191000128 | On the market | |
| EKG Receiver for Polar SA9330 | SA9330 | 07540191000203 | On the market | |
| Electrodes 100 Unigel Single T3425 | T3425 | 07540191000258 | On the market | |
| Flexcomp Infiniti Encoder SA7550 | SA7550 | 07540191000050 | On the market | |
| Forcetrac SA7600 | SA7600 | 07540191000098 | On the market | |
| Inclinotrac Sensor SA7650 | SA7650 | 07540191000074 | On the market | |
| NeuroInfiniti SA7550 | SA7550 | 07540191000678 | On the market | |
| Procomp 2 Encoder Device SA7400 | SA7400 | 07540191000029 | On the market | |
| Procomp 5 Encoder SA7525 | SA7525 | 07540191000043 | On the market | |
| Procomp Infiniti Encoder SA7500 | SA7500 | 07540191000036 | On the market | |
| Sensor, EEG FLEX/PRO SA9305M | SA9305M | 07540191000135 | On the market | |
| Sensor, EEG-Z Impedence Check SA9305Z | SA9305Z | 07540191000142 | On the market | |
| Sensor, EKG FLEX/PRO SA9306M | SA9306M | 07540191000159 | On the market | |
| Sensor, HR/BVP FLEX/PRO SA9308M | SA9308M | 07540191000166 | On the market | |
| Sensor, Myoscan EMG SA9503M | SA9503M | 07540191000227 | On the market | |
| Sensor, Myoscan-Pro 60Hz SA9401M-60 | SA9401M-60 | 07540191000210 | On the market | |
| Sensor, Myoscan-Z SA9503Z | SA9503Z | 07540191000234 | On the market | |
| Sensor, Respiration SA9311M | SA9311M | 07540191000197 | On the market | |
| Sensor, Skin Conductance SA9309M | SA9309M | 07540191000173 | On the market | |
| Sensor, Temperature SA9310M | SA9310M | 07540191000180 | On the market | |
| Switch Sensor Cable T9387M | T9387M | 07540191000395 | On the market | |
| TT A/V Sync Biofeedback sensor SA7670 | SA7670 | 07540191000111 | On the market | |
| TT pIR Sensor SA2600 | SA2600 | 07540191000081 | On the market | |
| TT- Infra Sensor SA2500 | SA2500 | 07540191000685 | On the market | |
| TT-EEG 2CH CONNECTIVITY KIT T8760 | T8760 | 07540191000333 | On the market | |
| TT-EEG 4CH CONNECTIVITY KIT T8761 | T8761 | 07540191000340 | On the market | |
| TT-EEG LINKED EAR ATTACHMENT KIT T8755 | T8755 | 07540191000326 | On the market | |
| TT-EEG MONO/BIPOLAR ELEC W/O DIN KIT T8751 | T8751 | 07540191000319 | On the market | |
| TT-EEG MONO/BIPOLAR ELECTRODE KIT T8750 | T8750 | 07540191000302 | On the market |
Similar devices
Other devices filed under FDA product code HCC (Device, Biofeedback).
- MINIATURE TEMPERATURE TRAINER MODEL DT-002 by Bio-Feedback Systems, Inc.
- SYNERGY PLUS by THE PROMETHEUS GROUP
- MYOSYSTEM 1000 ELECTROMYOGRAPH by Noraxon USA, Inc.
- Freespira by Palo Alto Health Sciences, Inc.
- THE BAGNOLI-4 EMG SYSTEM by DELSYS, INC.
- EMG MODEL 133 by Calnor of EL Paseo, Inc.
- FOCUS EMG by Fasstech
- MRS-2D by Lexicor Medical Technology, Inc.
- TMJOINT 1.0 BTSEMB1BM by BTS SPA
- EMG TRAINER by Unitech