Identity
- Trade Name
- MetaFlex FDA UDI
- Generic Name
- Compression/pressure glove FDA UDI
- Device Name
- The MetaFlex Glove combines targeted compression to enhance circulation with innovative resistance bands. This powerful combination may reduce pain while improving hand mobility and strength, promoting the functional use of your hands. FDA UDI
- Model / Reference
- 13437 FDA UDI
- Description
- The MetaFlex Glove combines targeted compression to enhance circulation with innovative resistance bands. This powerful combination may reduce pain while improving hand mobility and strength, promoting the functional use of your hands. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D481454 FDA UDI
- FDA Product Code
- ILH FDA UDI
- GMDN Term
- Compression/pressure glove FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
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: Compression/pressure gloveFinger/hand exerciser
MetaFlex by Ats Innovations — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Finger/hand exerciser.
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- T FOAM CUBE SOFT PINK 2x1.75x3IN 18/BX — AliMed, LLC · Class I
- PUTTY ALIMED THERAPY RED CODED 3OZ — AliMed, LLC · Class I
- Jux-a-cisor — Therafin Corporation · Class I
- B & C HAND THERAPY BALL W/LOGO — BIRD & CRONIN, LLC · Class I
- GRIP-X MAINT. GRADE GRN (10) DURO SPEC A65+ OR -2PTS (63-67) — AliMed, LLC · Class I
- PUTTY ALIMED THERAPY RED CODED 5LBS — AliMed, LLC · Class I
- PUTTY LIGHT PURPLE SOFT 4OZ 0.2 LBS PER 4 OZ CONTAINER — AliMed, 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
- Ats Innovations
Sources (1)
- FDA UDI 8a8d76da-70fc-4411-b6f0-be08defdf55f 34 fields · synced May 30, 2026