Identity
- Trade Name
- Aretech Premium Harness FDA UDI
- Generic Name
- Gait rehabilitation system harness FDA UDI
- Device Name
- Size: Large (waist circumference measured 2" below belly button: 36 - 41 inches). The Aretech Premium Harness is designed for use with Aretech products. FDA UDI
- Model / Reference
- AH-0L FDA UDI
- Description
- Size: Large (waist circumference measured 2" below belly button: 36 - 41 inches). The Aretech Premium Harness is designed for use with Aretech products. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850018836128 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Gait rehabilitation system harness FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gait rehabilitation system harness
Aretech Premium Harness by Aretech, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aretech, Llc
Sources (1)
- FDA UDI 931bae8c-fb14-4336-9147-8b11d1d34ce1 34 fields · synced May 30, 2026