Identity
- Trade Name
- OvationULT FDA UDI
- Generic Name
- Red/infrared light phototherapy unit FDA UDI
- Device Name
- The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles. This is the same product as the other OvationULT listing however it is for a private labelled distributer. FDA UDI
- Model / Reference
- SST FDA UDI
- Description
- The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles. This is the same product as the other OvationULT listing however it is for a private labelled distributer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009854536 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Red/infrared light phototherapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 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
Yes
FDA UDI
Category: Red/infrared light phototherapy unit
OvationULT by Body Balance System — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Red/infrared light phototherapy unit.
- LED RED Light Therapy Panel — Shenzhen RedV Medical Equipment CO., LTD · Class II
- Benilight — Benilight · Class II
- ZONN — Zonnsmart Science & Technology Co., Ltd · Class II
- LED Light Therapy Eye Mask — Shenzhen RedV Medical Equipment CO., LTD · Class II
- LED RED Light Therapy Panel — Shenzhen RedV Medical Equipment CO., LTD · Class II
- LED RED Light Therapy Panel — Shenzhen RedV Medical Equipment CO., LTD · Class II
- LED Light Therapy Neck Mask — Shenzhen RedV Medical Equipment CO., LTD · Class II
- LED Light Therapy Eye Mask — Shenzhen RedV Medical Equipment CO., LTD · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Body Balance System
Sources (1)
- FDA UDI 4131a13f-c48a-4092-b046-08aa4660acc8 35 fields · synced May 31, 2026