Identity
- Trade Name
- Comfy Curve Massage Pro FDA UDI
- Generic Name
- Hand-held electric massager FDA UDI
- Device Name
- The Comfy Curve Massage Pro device is an electrically powered, vibrating therapeutic massager. The device consists of a memory foam pillow with a small internal motor, powered by (2) AA batteries (not included), that vibrates the entire pillow. The Comfy Curve Massage Pro is an OTC device that is intended to be used on the body for relief of minor aches and pains. FDA UDI
- Model / Reference
- CCPMP-MC3 FDA UDI
- Description
- The Comfy Curve Massage Pro device is an electrically powered, vibrating therapeutic massager. The device consists of a memory foam pillow with a small internal motor, powered by (2) AA batteries (not included), that vibrates the entire pillow. The Comfy Curve Massage Pro is an OTC device that is intended to be used on the body for relief of minor aches and pains. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850018026161 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 18 Inch FDA UDI
Category: Hand-held electric massager
Comfy Curve Massage Pro by Spark Innovators Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held electric massager.
- Massage Gun — ShenZhen Pentasmart Technology Co, .Ltd · Class I
- G5® — GENERAL PHYSIOTHERAPY INC · Class I
- D-ACTOR® — Storz Medical AG · Class I
- RENPHO Eye Massager — JOICOM CORPORATION · Class I
- Maptag — Sanwei Taige (Suzhou) Medical Co., Ltd. · Class I
- Homedics — Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd. · Class I
- PM-750 — PRO MEDICAL SUPPLIES, INC. · Class I
- Homedics — ZHANGZHOU EASEPAL INNOVATION CO., LTD. · 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
- Spark Innovators Corporation
Sources (1)
- FDA UDI 68590752-1301-4272-ad57-955b6852dba9 36 fields · synced Jun 8, 2026