NTI-1000
FDA 510(k) clearance K894097 · decided 1989-09-25
Clearance details
- K-number
- K894097
- Device name
- NTI-1000
- Applicant
- Neurotek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-09
- Decision date
- 1989-09-25
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- QJQ
- Device class
- 2
- Regulation number
- 882.5800
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Olathe, KS, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| Modius Sleep (K230826) | Neurovalens , Ltd. | 2023-10-27 |
| Cervella (K182311) | Innovative Neurological Devices, LLC | 2019-03-07 |
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| ELEXOMA MEDIC (K070412) | Redplane AG | 2008-05-21 |
| CES ULTRA (K062284) | Neuro-Fitness, LLC | 2007-04-05 |
| NET-2000 MICROCURRENT STIMULATOR (K060158) | Auri-Stem Medical, Inc. | 2006-10-13 |
| TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 (K024377) | Kalaco Scientific, Inc. | 2003-07-21 |
| NH-2002 (K932050) | New Horizon Health Care | 1995-06-05 |
| ALPHA-STIM CS (K903014) | Electromedical Products, Inc. | 1992-05-12 |
| LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR (K910616) | Life Balance Intl., Inc. | 1992-05-12 |
Recalls involving this device
No recalls on record reference this clearance.