Identity
- Trade Name
- WORK HARDENING STARTUP PACKAGE FDA UDI
- Generic Name
- Chest-press exerciser FDA UDI
- Model / Reference
- SYSTEM-I FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840314806475 FDA UDI
- FDA Product Code
- IOD FDA UDI
- GMDN Term
- Chest-press exerciser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5350 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chest-press exerciser
Work Hardening Startup Package by Hausmann Enterprises, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chest-press exerciser.
- EN-Dynamic Chest Press — Enraf-Nonius B.V. · Class I
- WORK HARDENING, SYSTEM II w/8920 — HAUSMANN ENTERPRISES, LLC · Class I
- WORK HARDENING INTERMEDIATE PACKAGE — HAUSMANN ENTERPRISES, LLC · Class I
- Startup Package, 7 Items — HAUSMANN ENTERPRISES, LLC · Class I
- Intermediate Package, 8 Items — HAUSMANN ENTERPRISES, LLC · Class I
- SLED STATION, 24X40 — HAUSMANN ENTERPRISES, LLC · 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
- Hausmann Enterprises, Llc
Sources (1)
- FDA UDI b6ded14a-3cd0-4f4f-8fde-b5ca1c88fba1 32 fields · synced May 31, 2026