Identity
- Trade Name
- TensCare FDA UDI
- Generic Name
- Hand-held electric massager FDA UDI
- Device Name
- The Oko Eye Massager uses air pressure, vibration and hot compress cycle technology to massage the temples and key eye acupressure points. Massage of these points can help provide relief from eye fatigue, soothe headaches, reduce dark circles under the eyes, whilst also providing a relaxing affect to reduce anxiety, lower stress and assist falling to sleep. FDA UDI
- Model / Reference
- Oko FDA UDI
- Description
- The Oko Eye Massager uses air pressure, vibration and hot compress cycle technology to massage the temples and key eye acupressure points. Massage of these points can help provide relief from eye fatigue, soothe headaches, reduce dark circles under the eyes, whilst also providing a relaxing affect to reduce anxiety, lower stress and assist falling to sleep. FDA UDI
Identifiers
- Catalog Number
- K-OKO FDA UDI
- Primary DI / UDI-DI
- 05033435136995 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Hand-held electric massager FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 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
No
FDA UDI
Over-the-Counter
Yes
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
Category: Hand-held electric massager
TensCare by Tenscare Limited — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Tenscare Limited
Sources (1)
- FDA UDI b11f712b-f795-4d5f-8020-8fee56a9bdca 34 fields · synced Jun 1, 2026