Identity
- Trade Name
- CyMedica e-vive TENS Electrode Set FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- CyMedica e-vive TENS Electrode Set FDA UDI
- Model / Reference
- CY-1000-021 FDA UDI
- Description
- CyMedica e-vive TENS Electrode Set FDA UDI
Identifiers
- Catalog Number
- CY-1000-021 FDA UDI
- Primary DI / UDI-DI
- 00854816006769 FDA UDI
- 510(k) Number
- K163067 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 2 Inch FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
CyMedica e-vive TENS Electrode Set by Motive Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Physical therapy transcutaneous neuromuscular electrical stimulation system.
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Cleared under the same submission
K163067 also covers:
- CyMedica e-vive™ NMES Electrode Set without Backings — Motive Health, Inc.
- e-vive BILATERAL NMES SYSTEM; 2X / 3X (2.0 Dock) — Motive Health, Inc.
- e-vive BILATERAL NMES SYSTEM; EXTRA-SMALL (2.0 Dock) — Motive Health, Inc.
- e-vive BILATERAL NMES SYSTEM; LARGE / XL (2.0 Dock) — Motive Health, Inc.
- e-vive BILATERAL NMES SYSTEM; SMALL / MEDIUM (2.0 Dock) — Motive Health, Inc.
- e-vive Electrode Covers — Motive Health, Inc.
- e-vive NMES System — Motive Health, Inc.
- e-vive NMES System — Motive Health, Inc.
- e-vive NMES System — Motive Health, Inc.
- e-vive NMES System — Motive Health, Inc.
- e-vive NMES System — Motive Health, Inc.
- e-vive NMES System — Motive Health, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Motive Health, Inc.
Sources (1)
- FDA UDI 547f247e-72b8-4cd0-9270-5f19530a7aa5 38 fields · synced May 31, 2026