Identity
- Trade Name
- BioStamp nPoint™ FDA UDI
- Generic Name
- Kinesiology/electromyographic sensor set FDA UDI
- Device Name
- Web application FDA UDI
- Model / Reference
- SW-0028 FDA UDI
- Description
- Web application FDA UDI
Identifiers
- Primary DI / UDI-DI
- G012SW0028 FDA UDI
- 510(k) Number
- K173510 FDA UDI
- FDA Product Code
- MWI FDA UDILEL FDA UDIIKN FDA UDIDRG FDA UDI
- GMDN Term
- Kinesiology/electromyographic sensor set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI882.5050 FDA UDI890.1375 FDA UDI870.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biomechanical function analysis/rehabilitation softwareElectrocardiography telemetric monitoring system transmitterKinesiology/electromyographic sensor setKinesiology ambulatory recorder
BioStamp nPoint™ by Medidata Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electromyography telemetric monitoring system transmitter.
- DataLITE LE230 Wireless EMG Sensor — BIOMETRICS LIMITED · Class II
- BioStamp nPoint™ — Medidata Solutions, Inc. · Class II
- BioStamp® nPoint — Medidata Solutions, Inc. · Class II
- BioStamp nPoint™ — Medidata Solutions, Inc. · Class II
- BioStamp® — Medidata Solutions, Inc. · Class II
- BioStamp nPoint™ — Medidata Solutions, Inc. · Class II
- BioStamp® — Medidata Solutions, Inc. · Class II
- BioStamp nPoint™ — Medidata Solutions, Inc. · Class II
Cleared under the same submission
K173510 also covers:
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, Inc.
- BioStamp nPoint™ — Medidata Solutions, 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
- Medidata Solutions, Inc.
Sources (1)
- FDA UDI a84e3a4d-3bf8-4244-9b5c-90484d2ac041 35 fields · synced Jun 8, 2026