Identity
- Trade Name
- BodyMed FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- BODYMED ANALOG DUAL CHANNEL TENS/EMS COMBINATION UNIT WITH TIMER INCLUDES INCLUDES 2 LEAD WIRES, 1 PACK OF 4-1 3/4" ROUND CLOTH ELECTRODES, 9 VOLT BATTERY, CARRYING CASE, MANUAL FDA UDI
- Model / Reference
- ZZAEV806 FDA UDI
- Description
- BODYMED ANALOG DUAL CHANNEL TENS/EMS COMBINATION UNIT WITH TIMER INCLUDES INCLUDES 2 LEAD WIRES, 1 PACK OF 4-1 3/4" ROUND CLOTH ELECTRODES, 9 VOLT BATTERY, CARRYING CASE, MANUAL FDA UDI
Identifiers
- Catalog Number
- ZZAEV806 FDA UDI
- Primary DI / UDI-DI
- 00815802014519 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
BodyMed by Boxout, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Boxout, Llc
Sources (1)
- FDA UDI 1f768c20-f7ad-431c-8b61-029db3e04797 35 fields · synced Jun 6, 2026