Identity
- Trade Name
- IHN FDA UDI
- Generic Name
- Lower limb sliding exerciser, non-powered FDA UDI
- Device Name
- 3x10=0 Full Extension Knee Device FDA UDI
- Model / Reference
- 40015 FDA UDI
- Description
- 3x10=0 Full Extension Knee Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011457800 FDA UDI
- FDA Product Code
- HST FDA UDI
- GMDN Term
- Lower limb sliding exerciser, non-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.5850 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lower limb sliding exerciser, non-powered
Ihn by Ihn, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lower limb sliding exerciser, non-powered.
- BIOS Living — Thermor Ltd · Class I
- IHN — IHN, INC · Class I
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
- Ihn, Inc
Sources (1)
- FDA UDI 125ff3e7-419e-4375-b67b-a0ec3c6de609 34 fields · synced Jun 8, 2026