DEVICE: OvationULT (00860009854536)

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Device Record History
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Device Identifier (DI) Information
OvationULT
SST
In Commercial Distribution

Body Balance System, LLC
00860009854536
GS1

1
876724449 *Terms of Use
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.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
65723 Red/infrared light phototherapy unit
An electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ILY Lamp, Infrared, Therapeutic Heating
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 0 and 50 Percent (%) Relative Humidity
Storage Environment Temperature: between 65 and 85 Degrees Fahrenheit
Handling Environment Temperature: between 65 and 85 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 50 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
4131a13f-c48a-4092-b046-08aa4660acc8
June 03, 2025
6
June 21, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
2086971552
xx@xx.com
5102070130
xx@xx.com
7246523202
xx@xx.com
8634502925
xx@xx.xom
8163652624
xx@xx.com
6026251207
xx@xx.com
8154055683
xx@xx.com
7864716273
xx@xx.com
7852281815
xx@xx.com
7403528191
xx@xx.com
2188416203
xx@xx.com
7722203174
xx@xx.com
6032359032
xx@xx.com
7163079598
xx@xx.com
7893686688
xx@xx.com
5597328267
xx@xx.com
6199295090
xx@xx.com
9045716051
xx@xx.com
8167188095
xx@xx.com
4197069878
xx@xx.com
8472937423
xx@xx.com
5177873712
XX@XX.COM
3109625984
XX@XX.COM
8015093556
xx@xx.com
2068897940
xx@xx.com
5705692603
xx@xx.com
619-871-0566
XX@XX.COM
6198710566
XX@XX.COM
5022299519
XX@XX.COM
9315575061
XX@XX.COM
6108618885
xx@xx.com
8477918936
xx@xx.com
2703173980
xx@xx.com
9203091645
xx@xx.com
(616) 846-4100
XX@XX.COM
2077765217
xx@xx.com
9415247163
xx@xx.com
3042882018
xx@xx.com
2188338267
xx@xx.com
7012208412
xx@xx.com
8634502925
xx@xx.com
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