Identity
- Trade Name
- Vibrating Glove EUDAMEDIntellinetix FDA UDI
- Generic Name
- Circulatory/musculoskeletal vibration therapy unit, hand-held FDA UDI
- Device Name
- Intellinetix® Vibrating Glove EUDAMEDVibrating therapeutic massager FDA UDI
- Model / Reference
- 07230 EUDAMEDFDA UDISmall EUDAMED
- Description
- Vibrating therapeutic massager FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821610723000 EUDAMED00082161072300 FDA UDI
- Basic UDI-DI
- 082161INTELLIVGJ4 EUDAMED
- FDA Product Code
- ISA FDA UDI
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
- GMDN Term
- Circulatory/musculoskeletal vibration therapy unit, hand-held FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5660 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Circulatory/musculoskeletal vibration therapy unit, hand-held
Intellinetix by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Circulatory/musculoskeletal vibration therapy unit, hand-held.
- Intellinetix — BROWNMED, INC. · Class I
- Intellinetix — BROWNMED, INC. · Class I
- Intellinetix — BROWNMED, INC. · Class I
- Intellinetix — BROWNMED, INC. · Class I
- Intellinetix — BROWNMED, INC. · Class I
- Intellinetix — BROWNMED, INC. · Class I
- Intellinetix — BROWNMED, INC. · Class I
- Intellinetix — BROWNMED, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
Sources (2)
- FDA UDI 3e1f1be0-5c34-49c9-9ef2-e9478a3ae1cd 33 fields · synced Jun 19, 2026
- EUDAMED 9666ad13-c3bd-4245-8de7-18c8b72fc5c4 61 fields · synced Jun 19, 2026