FDA UDI
In Commercial Distribution
🇺🇸 United States
NormaTec
DI: 00810050286077
·
Model: Normatec Elite/JPN11-SH
·
NORMATEC INDUSTRIES LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NormaTec
- Primary DI
- 00810050286077
- Version / Model
- Normatec Elite/JPN11-SH
- Company Name
- NORMATEC INDUSTRIES LP
- Labeler DUNS
- 111448069
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-26
- Public Version
- 2
- Public Version Date
- 2024-05-31
- Public Version Status
- Update
- Public Device Record Key
- 737d7e67-0802-4105-93a7-19a715262090
Device Description
Normatec Elite short leg system is a powered air pressure inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | Physical Medicine | 890.5650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16837 | Sequential venous compression system | A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810050286077 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240122 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Short |