Sensus
by Neurometrix, Inc. 2 variants
510(k) K130919
Sensus is a medical device (FDA Class II; FDA product code GZJ, Stimulator, Nerve, Transcutaneous, For Pain Relief) made by Neurometrix, Inc., cleared under FDA 510(k) K130919 on 2 Jul 2013, 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 | NumberK130919 | Date2 Jul 2013 | StatusActive |
Official records
- FDA 510(k) database K130919
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GZJ
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K130919
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 | |||
|---|---|---|---|---|
| SENSUS SE-SK2 | SE-SK2 | 00851221006285 | — | No longer on the market |
| SENSUS SE-SK4 | SE-SK4 | 00851221006322 | — | No longer on the market |
| SENSUS SE-SY2 | SE-SY2 | 00851221006278 | — | No longer on the market |
| SENSUS SE-SY4 | SE-SY4 | 00851221006339 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief).
- CARE STIM by Care Rehab and Orthopaedic
- LUMISCOPE MICRO 100 by Lumiscope Co., Inc.
- ULTIMA TENS XL-A1 by TensCare Ltd
- MEDISANA DIGITAL TENS by Fuji Dynamics Limited
- ELECTRONEURAL STIMULATOR 12 by Meridia 12 Corp.
- BIO-STIMULATOR, MODEL 400 by Med-Western Electronics, Inc.
- NEMA-ST, MODEL V1.0.2 by Nervomatrix, Ltd.
- INTERCEPT T.E.N.S. DEVICE by Medical Design & Manufacturing Corp.
- SOLITENS MODIFIED by Innovative Designer Products, Inc.
- INTERX5000 by Neuro Resource Group, Inc.