Identity
- Trade Name
- Human Touch FDA UDI
- Generic Name
- Bed/chair electric massager FDA UDI
- Device Name
- A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use. FDA UDI
- Model / Reference
- WHOLEBODY ROVE, MOON FDA UDI
- Description
- A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use. FDA UDI
Identifiers
- Catalog Number
- 100-ROVE-002 FDA UDI
- Primary DI / UDI-DI
- 00045915830212 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Bed/chair 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: Bed/chair electric massager
Human Touch by Human Touch, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bed/chair electric massager.
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- Homedics — Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd. · Class I
- Homedics — Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd. · Class I
- Homedics — Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd. · Class I
- Homedics — Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd. · Class I
- Henglin — Henglin Home Furnishings Co., Ltd. · Class I
- Homedics — Smart Home Branch of Zhangzhou Easepal Industrial Corporation · Class I
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
- Human Touch, Llc.
Sources (1)
- FDA UDI 30e89cb0-4f20-4407-905b-df620f037e70 34 fields · synced Jun 8, 2026