Identity
- Trade Name
- Sit2Stand FDA UDI
- Generic Name
- Manual stander/exerciser FDA UDI
- Device Name
- SIT2STAND SQUAT-ASSIST TRAINER FDA UDI
- Model / Reference
- 950-560 FDA UDI
- Description
- SIT2STAND SQUAT-ASSIST TRAINER FDA UDI
Identifiers
- Catalog Number
- 950-560 FDA UDI
- Primary DI / UDI-DI
- 00718175005606 FDA UDI
- FDA Product Code
- ION FDA UDI
- GMDN Term
- Manual stander/exerciser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5370 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
Yes
FDA UDI
Category: Manual stander/exerciser
Sit2Stand by Biodex Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual stander/exerciser.
- VIVE — VIVE HEALTH LLC · Class I
- EasyStand — Altimate Medical, Inc. · Class II
- EasyStand — Altimate Medical, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biodex Medical Systems
Sources (1)
- FDA UDI 0ccf2a13-bd0e-4fb9-a62b-edd6ba05d463 34 fields · synced Jun 8, 2026