Calm Ultra
- Primary DI
- M750AR636B0
- Brand
- Calm Ultra
- Company
- NEURO-FITNESS LLC
- Model
- AR635A
- Catalog number
- Calm Ultra
- Device description
- Cranial Electrotherapy Stimulator
- Published
- 2026-07-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
Code, Name table| Code | Name |
|---|
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | Neurology | 2 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| M750AR636B0 | Primary | HIBCC | 0 | |
Regulatory Flags#
- DUNS number
- 078513618
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
Primary DI, Brand, Model table| Primary DI | Brand | Model | Catalog | Published |
|---|
| M750AR635A0 | CES-Ultra | AR635A | CES-Ultra | 2017-06-30 |
| M750AR635A | CES-Ultra | AR635A | CES-Ultra | 2017-02-12 |
Other Devices Sharing Product Codes#
cesultra.com