| Primary Device ID | 00817369020002 |
| NIH Device Record Key | de7117ef-554b-4242-8d7d-5bd572bfa8f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NormaTec Pulse |
| Version Model Number | JMS4 |
| Catalog Number | 10100 |
| Company DUNS | 111448069 |
| Company Name | NORMATEC INDUSTRIES LP |
| 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 | false |
| 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 |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817369020002 [Primary] |
| IRP | Massager, Powered Inflatable Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-13 |
| 00810050281713 - NormaTec | 2024-08-05 Normatec Hose Attachment |
| 00810050281812 - NormaTec | 2024-08-05 Normatec right arm attachment |
| 00810050286053 - NormaTec | 2024-05-31 Normatec Elite standard leg system is a powered air pressure inflatable tube massager. It is intended to temporarily relieve min |
| 00810050281997 - NormaTec | 2024-05-21 Normatec 3 is a powered air pressure inflatable tube massager. It is intended to temporarily relieve minor muscle aches and / o |
| 00810050286077 - NormaTec | 2024-05-06 Normatec Elite short leg system is a powered air pressure inflatable tube massager. It is intended to temporarily relieve minor |
| 00810050286084 - NormaTec | 2024-05-06 Normatec Elite tall leg system is a powered air pressure inflatable tube massager. It is intended to temporarily relieve minor m |
| 00810050281294 - NormaTec | 2023-06-26 |
| 00810050281720 - NormaTec | 2023-06-26 |