Identity
- Trade Name
- ONDAMED FDA UDI
- Generic Name
- Biofeedback system FDA UDI
- Device Name
- ONDAMED Flex Applicator FDA UDI
- Model / Reference
- 001-21-0101 FDA UDI
- Description
- ONDAMED Flex Applicator FDA UDI
Identifiers
- Catalog Number
- 001-21-0101 FDA UDI
- Primary DI / UDI-DI
- 00852318007215 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Biofeedback system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Biofeedback system
Ondamed by Ondamed Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biofeedback system.
- Bagnoli-8 EMG System — DELSYS, INC. · Class II
- Trigno Goniometer Adapter — DELSYS, INC. · Class II
- NeuroEDUCATOR — CONTROL BIONICS INCORPORATED · Class II
- Trigno EKG Biofeedback Sensor — DELSYS, INC. · Class II
- TeleMyo — Noraxon USA, Inc. · Class II
- MYOLAB II — MOTION CONTROL, INC. · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
- Bagnoli-16 EMG System — DELSYS, INC. · Class II
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
- Ondamed Inc.
Sources (1)
- FDA UDI 8ce64075-5fdc-475d-b92e-a3d914c07866 35 fields · synced May 30, 2026