Identity
- Trade Name
- PERFORMANCE HEALTH FDA UDI
- Generic Name
- Upper-limb mechanical weight exerciser, lever/pulley-cable FDA UDI
- Device Name
- Rolyan Reach ’N Range Pulley, Pulley with Metal Bracket FDA UDI
- Model / Reference
- A873624 FDA UDI
- Description
- Rolyan Reach ’N Range Pulley, Pulley with Metal Bracket FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216112445 FDA UDI
- FDA Product Code
- ION FDA UDI
- GMDN Term
- Upper-limb mechanical weight exerciser, lever/pulley-cable 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
Yes
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: Upper-limb mechanical weight exerciser, lever/pulley-cable
Performance Health by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Upper-limb mechanical weight exerciser, lever/pulley-cable.
- SilverStar, Wall Mounted Overhead Pulley — HAUSMANN ENTERPRISES, LLC · Class I
- RANIER ROMER W/OVERDOOR STRAP — BIRD & CRONIN, LLC · Class I
- THERATEK SIERRA ROMER W/STRAP — BIRD & CRONIN, LLC · Class I
- SIERRA ROMER W/OVERDOOR FRAME — BIRD & CRONIN, LLC · Class I
- SIERRA ROMER W/OVERDOOR STRAP — BIRD & CRONIN, LLC · Class I
- EN-Dynamic Triceps Dips — Enraf-Nonius B.V. · Class I
- EN-Dynamic Shoulder Press — Enraf-Nonius B.V. · Class I
- RANIER ROMER W/OVERDOOR FRAME — BIRD & CRONIN, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Asp Global, LLC
Sources (1)
- FDA UDI c3c334ff-ec21-405f-a20c-dc577de6e746 33 fields · synced May 30, 2026