| Primary Device ID | 00195893606580 |
| NIH Device Record Key | 72ff8c90-7303-4108-bce8-0e5eda73694f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enso Model 1 |
| Version Model Number | 100-001 |
| Company DUNS | 080601423 |
| Company Name | Hinge Health, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com | |
| Phone | 855-902-2777 |
| help@hingehealth.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195893606580 [Primary] |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-01 |
| Device Publish Date | 2022-01-24 |
| 00850045950057 - Enso | 2025-03-31 Nerve stimulator for pain relief (manufactured in Malaysia) - 2 back, 1 std gel pad |
| 00850045950064 - Enso | 2025-03-31 Nerve stimulator for pain relief (manufactured in Malaysia) - 2 std., 1 back gel pad |
| 00850045950026 - Enso | 2024-01-11 Nerve stimulator for pain relief (manufactured in Malaysia) |
| 00850045950033 - Enso | 2023-06-15 Nerve stimulator for pain relief (stand-alone unit) |
| 00850045950002 - Enso | 2022-09-28 Nerve stimulator for pain relief |
| 00850045950019 - Enso | 2022-09-28 Nerve stimulator for pain relief |
| 00195893670284 - Enso Model 2 | 2022-05-09 Nerve stimulator for pain relief |
| 00195893606580 - Enso Model 1 | 2022-02-01Nerve stimulator for pain relief |
| 00195893606580 - Enso Model 1 | 2022-02-01 Nerve stimulator for pain relief |