Identity
- Trade Name
- HUMAC Biodex System2 (R) FDA UDI
- Generic Name
- Back/leg/chest dynamometer FDA UDI
- Device Name
- HUMAC Biodex System2 Extremity System; Dynamometer – Refurbished FDA UDI
- Model / Reference
- 503677 FDA UDI
- Description
- HUMAC Biodex System2 Extremity System; Dynamometer – Refurbished FDA UDI
Identifiers
- Catalog Number
- 503677 FDA UDI
- Primary DI / UDI-DI
- 00860139000339 FDA UDI
- FDA Product Code
- IKK FDA UDI
- GMDN Term
- Back/leg/chest dynamometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Back/leg/chest dynamometer
HUMAC Biodex System2 (R) by Computer Sports Medicine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Back/leg/chest dynamometer.
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- HUMAC Biodex System3 Rev0 (R) — COMPUTER SPORTS MEDICINE, INC. · Class II
- HUMAC NORM (R) — COMPUTER SPORTS MEDICINE, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Computer Sports Medicine, Inc.
Sources (1)
- FDA UDI fbd5fbf8-c45e-444a-ac82-89c15ed25d05 36 fields · synced May 30, 2026