DEVICE: Ovation (00860009854529)
Device Identifier (DI) Information
Ovation
ULT
In Commercial Distribution
Body Balance System, LLC
ULT
In Commercial Distribution
Body Balance System, LLC
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.
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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
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 |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
5cf95e82-e23d-41b5-873b-2e3d4c179894
February 10, 2025
5
September 18, 2023
February 10, 2025
5
September 18, 2023
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
9412238628
dr.kate@integralhealingwellness.com 2818988738
jd@hytorctexas.com 6505494919
admin@therecoverzone.com 3609692707
ammannwellnesscenter@gmail.com 7659691159
shaun@wellfranchise.com 5038260565
reed351@gmail.com 5103043175
keri@khawkconsulting.com 7026068300
marylv@gmail.com 4327155690
tnchiro@gmail.com 7136283838
support@recovathlete.com 14805867654
bryce@hydroairlab.com 7138597919
billwolcott@sbcglobal.net 2104219397
tansations@gmail.com 7028132524
trichards@revlitesystems.com 8287120102
will@vyvewellness.com 2817727220
bill@glosunspa.com 5306819311
jdmnewp@gmail.com 17022509921
nikki@nikkibeeairbrushtanning.com 4022103495
drgoss@omahawellnesscenter.com 6144778470
ronan@reviverecharge.com 17752530807
drzac22@gmail.com 6788527757
michellebergeron@bellsouth.net 7022879872
rick@suntancity.com 3616499052
wirtz@suddenlink.net 6135998509
sonicwavefitness@gmail.com 6155174501
ben.follas@gmail.com 8479179525
kathryn.wollman@gmail.com 4692352987
lbates@canyonranch.com 5202393280
ralmada@canyonranch.com 8157879790
wainwrightm@mac.com 4695832188
sammy-ragsdale@att.net 3038080041
xx@xx.com 7026304404
pbayardo@primeivhydration.com 7029274799
hamead@gmail.com 5617798886
lindasingerisland@gmail.com 7074984100
xx@xx.com 4106603179
charmaine_101@msn.com 4148075258
wreimer1@iclouid.com 6514394662
heidi@justformespa.com 8435400107
compassrosehealth@gmail.com 2487708174
sara@7ware.com 9122533556
rjremnant@hotmail.com
dr.kate@integralhealingwellness.com 2818988738
jd@hytorctexas.com 6505494919
admin@therecoverzone.com 3609692707
ammannwellnesscenter@gmail.com 7659691159
shaun@wellfranchise.com 5038260565
reed351@gmail.com 5103043175
keri@khawkconsulting.com 7026068300
marylv@gmail.com 4327155690
tnchiro@gmail.com 7136283838
support@recovathlete.com 14805867654
bryce@hydroairlab.com 7138597919
billwolcott@sbcglobal.net 2104219397
tansations@gmail.com 7028132524
trichards@revlitesystems.com 8287120102
will@vyvewellness.com 2817727220
bill@glosunspa.com 5306819311
jdmnewp@gmail.com 17022509921
nikki@nikkibeeairbrushtanning.com 4022103495
drgoss@omahawellnesscenter.com 6144778470
ronan@reviverecharge.com 17752530807
drzac22@gmail.com 6788527757
michellebergeron@bellsouth.net 7022879872
rick@suntancity.com 3616499052
wirtz@suddenlink.net 6135998509
sonicwavefitness@gmail.com 6155174501
ben.follas@gmail.com 8479179525
kathryn.wollman@gmail.com 4692352987
lbates@canyonranch.com 5202393280
ralmada@canyonranch.com 8157879790
wainwrightm@mac.com 4695832188
sammy-ragsdale@att.net 3038080041
xx@xx.com 7026304404
pbayardo@primeivhydration.com 7029274799
hamead@gmail.com 5617798886
lindasingerisland@gmail.com 7074984100
xx@xx.com 4106603179
charmaine_101@msn.com 4148075258
wreimer1@iclouid.com 6514394662
heidi@justformespa.com 8435400107
compassrosehealth@gmail.com 2487708174
sara@7ware.com 9122533556
rjremnant@hotmail.com