Identity
- Trade Name
- H200 Wireless FDA UDI
- Generic Name
- Hand orthosis FDA UDI
- Device Name
- Clinician Programmer Software for H200 Wireless System FDA UDI
- Model / Reference
- H2W-SW01 FDA UDI
- Description
- Clinician Programmer Software for H200 Wireless System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810188050601 FDA UDI
- 510(k) Number
- K111767 FDA UDI
- FDA Product Code
- GZI FDA UDI
- GMDN Term
- Hand orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5810 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand orthosis
H200 Wireless by Bioness Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hand orthosis.
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- MyoPro — Myomo, Inc. · Class II
Cleared under the same submission
K111767 also covers:
- H200 Wireless System — Bioness Medical, Inc.
- H200 Wireless System — Bioness Medical, Inc.
- H200 Wireless System — Bioness Medical, Inc.
- H200 Wireless System — Bioness Medical, Inc.
- H200 Wireless System — Bioness Medical, Inc.
- H200 Wireless System — Bioness Medical, Inc.
- H200 Wireless System — Bioness Medical, Inc.
- H200 Wireless System — Bioness Medical, Inc.
- H200 Wireless System — Bioness Medical, Inc.
- H200 Wireless System — Bioness Medical, 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
- Bioness Medical, Inc.
Sources (1)
- FDA UDI 797adf1c-e506-44c2-8789-54d1178b4c46 35 fields · synced Jun 9, 2026