Identity
- Trade Name
- QB1 NMES SYSTEM, BILATERAL, SMALL/MEDIUM FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- QB1 NMES SYSTEM, BILATERAL, SMALL/MEDIUM FDA UDI
- Model / Reference
- QB-1000-251 FDA UDI
- Description
- QB1 NMES SYSTEM, BILATERAL, SMALL/MEDIUM FDA UDI
Identifiers
- Catalog Number
- QB-1000-251 FDA UDI
- Primary DI / UDI-DI
- 00854691008698 FDA UDI
- 510(k) Number
- K150413 FDA UDI
- FDA Product Code
- IPF FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 16 Inch FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Qb1 Nmes System, Bilateral, Small/Medium by Motive Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150413 also covers:
- QB1 Garment Strap Extender Kit — Motive Health, Inc.
- QB1 NMES SYSTEM, BILATERAL, 2X-LARGE/3XLARGE — Motive Health, Inc.
- QB1 NMES SYSTEM, BILATERAL, LARGE/XLARGE — Motive Health, Inc.
- QB1 NMES SYSTEM, BILATERAL, X-SMALL — Motive Health, Inc.
- QB1 NMES System — Motive Health, Inc.
- QB1 NMES System — Motive Health, Inc.
- QB1 NMES System — Motive Health, Inc.
- QB1 NMES System — Motive Health, Inc.
- QB1 NMES System — Motive Health, Inc.
- QB1 NMES System — Motive Health, Inc.
- QB1 NMES System — Motive Health, Inc.
- QB1 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Motive Health, Inc.
Sources (1)
- FDA UDI 7bc7e6fa-37e2-4d23-8c00-b6852e160b50 38 fields · synced May 30, 2026