Identity
- Trade Name
- miha bodytec FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- The “i-body connect wireless” is an extension for the control units “miha bodytec II” and “miha bodytec m.ove”. It serves as an external stimulation unit with a wireless connection to the control unit. i-body connect wireless makes it possible to train without a connection cable between the athlete and the control unit. FDA UDI
- Model / Reference
- i-body connect wireless FDA UDI
- Description
- The “i-body connect wireless” is an extension for the control units “miha bodytec II” and “miha bodytec m.ove”. It serves as an external stimulation unit with a wireless connection to the control unit. i-body connect wireless makes it possible to train without a connection cable between the athlete and the control unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260646650021 FDA UDI
- 510(k) Number
- K221498 FDA UDI
- FDA Product Code
- NGX FDA UDIIPF 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
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
miha bodytec by Miha Bodytec GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K221498 also covers:
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
- Miha Bodytec GmbH
Sources (1)
- FDA UDI fc4a4f88-5658-4eff-955a-bc47a17e49b8 34 fields · synced May 31, 2026